38
APPRENTICESHIP CURRICULUM for Quality Control Chemist Under Life Sciences for NSQF compliance National Apprenticeship Promotion Scheme
APPRENTICESHIP CURRICULUM
for
Quality Control Chemist
Under
Life Sciences
for
NSQF compliance
National Apprenticeship Promotion
Scheme
1 Program Title Quality Control Chemist
2 Program Code, if any LFS/Q1301
3 Any related NSQF approved QP/Course/NOS and code
LFS/Q1301- Quality Control Chemist 1. LFS/N0301 Perform routine
analysis in lab while ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
2. LFS/N0101 Maintain a healthy, safe and secure working environment in the life sciences facility
3. LFS/N0302 Coordinate with Supervisors and colleagues within and outside the department
4. LFS/N0103 Ensure cleanliness in the work area
5. LFS/N0314 Carry out reporting and documentation to meet quality standards
6. LFS/N0320 Carry out quality checks in the quality control process
4 Hours for Basic Training (Block I) 480 Hours / 2.4 Months (Exempted for trainees with B. Pharma. education qualification)
5 Hours for On the Job Training (Block II) 1840 Hours / 9.6 Months
6 Certifying body for Basic Training Program Life Sciences Sector Skill Development Council
7 Certifying Body for On the Job training Industry/ Industries from Life Sciences Sector
8 Any Licensing requirements, wherever applicable
NA
9 Minimum eligibility criteria (Educational and/ or technical Qualification) Exemptions, if any
B. Pharma / B. Sc. with Chemistry major subject or Analytical Chemistry (Preferable) Basic Training is Exempted for B. Pharma. qualified trainees
10 Trainer’s Qualification and Experience Graduate with 4 years relevant exp. or Post Graduate with 2-year relevant exp.
11 NCO code and occupation NCO-2004/ 2113.02, Quality
12 Proposed NSQF level 5
13 Indicative list of training tools required to deliver this qualification (may be attached)
Attached in Annexure A
14 Formal structure of the curriculum
Modules Notional hours- Theory
Notional hours- Practical
Total duration
Basic Training Program
1.Outline Life Sciences Sector and relevant regulations 2.Explain Production Process for Life Sciences Industry 3.Use fundamentals of Instrumental Analysis 4.Perform Sample Preparation, preservation and Storage as per GLP 5.Operate Analytical Instruments as per GLP and SOP 6.Perform Quality Checks in Quality Control Process as per GLP, GMP and SOP 7.Complete Documentation for Quality Control as per GDP 8.Maintain a healthy, safe and secure working environment in the pharmaceutical manufacturing facility and laboratory 9.Ensure Cleanliness in the work area
10:00 10:00 10:00 07:00 34:00 14:00 12:00 16:00 08:00
00:00 10:00 25:00 25:00 144:00 25:00 15:00 15:00 16:00
10 Hours 20 Hours 35 Hours 32 Hours 178 Hours 39 Hours 27 Hour 31 Hours 24 Hours
10.Coordinate with Supervisor, within team and cross functional the teams 11.Use Information Technology Skills in QC and follow 21 CFR Part 11 rules
16:00 16:00
10:00 25:00
26 Hours 41 Hours
On the Job Training Program
1.Maintain Safety and Hygiene 2.Maintain QC Lab and its instruments as per GLP 3.Practice rules as per GMP,GLP and SOP 4.Complete Documentation in QC as per GLP and GDP 5.Use General Instruments in QC Lab 6.Follow Sampling procedure 7.Perform Sample preparation and processing 8.Perform Waste disposal and Management as per GMP and EHS rules 9.Operate HPLC 10.Operate FTIR (Fourier Transform Infra-Red Radiation) 11.Operate Gas Chromatography(GC) 12.Perform Chemical Analysis for QC Samples 13. Perform Analytical method Validation
00:00 00:00 40:00 40:00 32:00 16:00 40:00 16:00 32:00 32:00 32:00 32:00 40:00
16:00 24:00 80:00 120:00 80:00 144:00 200:00 64:00 160:00 160:00 160:00 160:00 120:00
16 Hours 24 Hours 120 Hours 160 Hours 112 Hours 160 Hours 240 Hours 80 Hours 192 Hours 192 Hours 192 Hours 192 Hours 160 Hours
15 Total Pass marks
Pass Marks-Theory Pass Marks- Practical
Basic Training Program 279
321
On the Job Training Program
0
100
16 Job description-brief A Quality Control Chemist prepares and tests samples from all phases of the manufacturing process to ensure that the product quality meets the standards, prepares documents that report test results and is responsible for preserving workplace safety while handling hazardous materials. Also responsible for testing of in-process/input raw materials & packing materials, in-process samples apart from finished products. Also responsible for testing of process validation samples, product stability samples and cleaning validation samples (Rinse samples/Swab samples etc.).
17 Progression from the qualification (Please show Professional and academic progression)
Upward progression:
QC Manager (Level 6)
Lateral/ Horizontal progression:
Quality Assurance Chemist (Level 5)
Quality Management System In charge (Level 5)
18 Employment avenues/opportunities
The candidates after their tenure as apprentice may do any of the following: a. Quality Control Chemist (immediately) b. Quality Assurance Chemist (with 2-3 years exp.) c. Quality Management System In charge (with 2-3 years exp.) d. Quality Control Manager (5 years of Exp.)
19 Assessment strategy (Basic training and On the Job)
Attached in Annexure B
20 Curriculum update V1.0, 08/12/2018 version and date
21 Curriculum revision date 08/04/2022
Curriculum
Module Name with duration
Key Learning outcomes
Theory/Basic Training Program- Block I
Outline Life Sciences Sector and relevant regulations Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 00:00 Corresponding NOS Code LFS/N0301 LFS/N0314 LFS/N0302
Explain the overview of Life Sciences industry in Indian and global context
Explain regulatory authorities and government policies, rules and regulations and their impact on quality control operations in Life Sciences industry
Follow legislation, standards (GMP, GLP, GDP), policies, regulations and procedures used in the life sciences organization relevant to quality control chemist job role
Recall the organization structure and employment benefits in Life Sciences organizations
Outline the role of a Quality Control chemist, required skills and knowledge (As per Qualification Pack) and its career path
Explain Production Process for Life Sciences Industry Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 10:00 Corresponding NOS Code LFS/N0301 LFS/N0302 LFS/N0320 LFS/N0314
Describe various steps of API production and formulation production process
Interpret basics of formulation like route of drug administration, dosage forms and their relevant benefits
Identify critical quality attributes (CQA), critical process parameters (CPP) and critical process controls (CPC) and follow l quality management system for quality control in Life Sciences industry as per GMP
Use Fundamentals of Instrumental Analysis Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 25:00 Corresponding NOS Code LFS/N0301 LFS/N0320
Implement basics of pharmaceutical science and chemistry for test and analysis
Perform assay and calculation as per SOP
Follow basic principles of separation science use in quality control analysis
Perform Sample Preparation, preservation and Storage as per GLP Theory Duration (hh:mm) 34:00 Practical Duration (hh:mm) 144:00 Corresponding NOS Code LFS/N0301
Follow standards and guidelines for sample handling in Life Science industry
Perform sampling procedures as per SOP’s by utilizing appropriate sampling tools
Implement sampling plans for sampling of materials
Perform sample handling and preparation
Follow guidelines for weighing of samples
Outline the toxicity and carcinogenicity while handling critical samples.
Follow the Good Storage Practices
Explain stability of sample and implement process of sample stabilization
Identify and report nonconformity of the material as per SOP
Operate Analytical Instruments as per GLP and SOP Theory Duration (hh:mm) 34:00 Practical Duration (hh:mm) 144:00
Operate analytical instrument and equipment for analysis of test sample
Summarize the basic application of analytical instruments
Explain basic principles of analytical instruments
Perform calibration and validation of analytical instrument as per SOP and manual
Perform maintenance procedure for instruments as per SOP
Corresponding NOS Code LFS/N0301
Perform Quality Checks in Quality Control Process as per GLP, GMP and SOP Theory Duration (hh:mm) 14:00 Practical Duration (hh:mm) 25:00 Corresponding NOS Code LFS/N0320 LFS/N0314
Perform quality check in QC lab and compare results with statistical limits
Perform calibrations, IQ, OQ, PQ and techniques for improving instrumental analysis
Verify checklist for instruments used for QC analysis
Deal with equipment malfunction and report faults during the equipment breakdown as appropriate
Carry out statistical analysis of laboratory data
Use advance QC approaches like quality by design and process analytical technology and method transfer process
Practice practical problem solving/ trouble shooting in QC analysis
Complete Documentation for Quality Control as per GDP Theory Duration (hh:mm) 12:00 Practical Duration (hh:mm) 15:00 Corresponding NOS Code LFS/N0301 LFS/N0302 LFS/N0314 LFS/N0320
Read and compose reports in pre-decided format both Offline and online as per SOPs
Select the correct method of documentation as per SOPs and GMP protocols
Report in time about each incident
Adapt validation process of document as per GMP protocols
Identify and report incidents where SOP are not followed
Adapt escalation matrix for decision making that is not defined in SOP
Record & describe the work done in local language and/ or English
Use efficient and clear communication methods for reporting the incidents and communication with team
Maintain a healthy, safe and secure working environment in
Follow procedures and guidelines for personal protective equipment (PPE) and other safety regulations in Quality Control lab
Ensure that work area is clean and safe from hazards
the pharmaceutical manufacturing facility and laboratory Theory Duration (hh:mm) 16:00 Practical Duration (hh:mm) 15:00 Corresponding NOS Code LFS/N0101
Recall the basic concepts of safety including Hazards, Accidents, Safety Signs and Signals and Heinrich Pyramid and practice same in QC lab
Outline functioning of utility systems at Plant
Use Material Data Safety Sheet and follow the Process of Safety Analysis
Follow the Fire Safety concepts and prepare oneself to act in case of Fire Emergency in QC lab
Provide the critical information to concerned team members and supervisor
Follow the emergency procedures and perform first aid in case of accident
Practice professional skills
Ensure Cleanliness in the work area Theory Duration (hh:mm) 08:00 Practical Duration (hh:mm) 16:00 Corresponding NOS Code LFS/N0103
Carry out cleaning procedure of equipment as per SOP
Identify importance of working in clean and safe environment in life sciences Industry
Follow guidelines for spillage and waste management
Operator electronic and optical sensors in laboratory equipment as per SOP
Carry out disposal methods for waste, used/ unused solutions as per SOP
Comply with health and safety, environmental and other relevant regulations and guidelines at work
Practice professional skills
Coordinate with Supervisor, within team and cross functional the teams Theory Duration (hh:mm) 16:00 Practical Duration (hh:mm) 10:00
Follow general reporting process, protocol and escalation policy
Submit the reports and other GMP and testing related documents as per SOP
Use techniques for collaborating with other groups and divisions in order to achieve organizational goals
Face Internal Audit interactions in English or local language
Explain the importance of cGMP/QMS/ SOP related documentation
Use the appropriate method for responding to audit queries
Use IT tools in communication and coordination
Practice core communication skills and professional skills to meet the work output requirements
Corresponding NOS Code LFS/N0302 LFS/N0314
Use Information Technology Skills in QC and follow 21 CFR Part 11 rules Theory Duration (hh:mm) 16:00 Practical Duration (hh:mm) 25:00 Corresponding NOS Code LFS/N0314
Use IT tools for data entry in e-documents wherever needed
Maintain the confidentiality of the data and internal processes
Use different software to operate the QC instruments
Comply with the requirements of 21 CFR Part 11
Maintain information security while using e-mail and other official communication channels
Maintain online records
On the Job Training Program- Block II
Maintain Safety and Hygiene Theory Duration 0 Days OJT Duration 2 days Corresponding NOS Code LFS/N0101
Practice laboratory safety by following gowning procedures as per SOP
Use personal protective equipment while performing test and analysis
Follow the fire safety concepts and prepare oneself to act in case of fire emergency in QC lab
Follow process safety management
Follow chemical safety as per SOP
Interpret material safety data sheets (MSDS)
Follow organization guidelines for spillage and waste management
Maintain QC Lab and its instruments as per GLP Theory Duration 0 Days OJT Duration 3 Days
Perform the role of a Quality Control Chemist as per the job key responsibility areas (KRA)
Explain regulatory authorities, government policies, rules and regulations followed by the organization (USFDA, WHO, Domestic etc) and licenses owned.
Adapt reporting and escalation matrix of the organization
Perform basic role and functions in QC laboratory in the organization
Explain existing lab infrastructure, equipment and relevant usage
Corresponding NOS Code LFS/N0301, LFS/N0314, LFS/N0302
Practice rules as per GMP, GLP and SOP Theory Duration 05 days OJT Duration 10 Days Corresponding NOS Code LFS/N0301, LFS/N0314, LFS/N0302
Follow legislation, GxP standards, policies, regulations and procedures in organisation
Carry out SOP reading and writing as per guidelines
Explain QMS for quality control
Complete Documentation in QC as per GLP and GDP Theory Duration 05 days OJT Duration 15 days Corresponding NOS Code LFS/N0301, LFS/N0302, LFS/N0314, LFS/N0320
Explain types of documents and records such as Bills of Materials (BOMs),Specifications, Policies, Protocols ,Standard Operating Procedures (SOPs),Work Instructions(WIs),Test Methods, Checklists, Forms/Log sheets, Training Assessments, Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventive, actions, internal inspection, change control, training records etc.),Certificate of Analyses (CoA) or Certificate of Compliance (CoC), Technical transfer reports, Validation documentation
Follow and maintain data integrity
Read and write instructions and procedures in clear and unambiguous language
Carry out reporting and documentation as per Quality standards and SOP’s
Use General Instruments in QC Lab Theory Duration 05 Days OJT Duration 10 days Corresponding NOS Code
Operate analytical equipment’s and Instruments like UV-Visible Spectrophotometer, Dissolution Tester, Disintegration Tester, Friabilator, Hardness Tester and Electronic balances. (Micro, Semi Micro and Analytical Balance), Auto titrator, Flame photometers, TOC analyser, Bubble point tester
Perform In-house validation/calibration procedure for equipment used in the organization laboratory
Perform weighing procedure as per prescribed guidelines, good weighing practices and calibration of weighing balance
Operate pH meter, conductivity meter, TOC, Hardness tester
LFS/N0301 LFS/N0103
Follow Sampling procedure Theory Duration 2 Days OJT Duration 18 Days Corresponding NOS Code LFS/N0301, LFS/N0103
Explain classification of sampling material i.e. starting materials, intermediates, pharmaceutical products (in-process as well as before and after packaging); primary and secondary packaging materials; and cleaning and sanitizing agents, compressed gases and other processing agents.
Perform sampling procedures as per SOP’s by utilizing appropriate sampling tools
Recall and follow the sampling plan for sampling of materials
Able to identify and report nonconformity of the material as per the organization procedures
Perform Sample preparation and processing Theory Duration 05 Days OJT Duration 25 days Corresponding NOS Code LFS/N0301, LFS/N0103
Prepare sample as per SOP’s for analysis of raw materials, intermediated and finished goods
Perform storage of samples as per SOP
Follow the SOP for handling the critical samples
Ensure sample storage and disposal as per SOP
Perform Waste disposal and Management as per GMP and EHS rules Theory Duration 02 Days OJT Duration 08 days Corresponding NOS Code LFS/N0301
Explain pharmaceutical wastes category
Follow the procedures for disposal of pharmaceutical waste
Perform disposal of halogenated compounds
Summarize and implement waste management technology
Operate HPLC Theory Duration 05 Days OJT Duration 25 days Corresponding NOS Code LFS/N0301
Recognize normal phase and reverse phase
Explain about different kind of detectors used
Comply with regulatory guidelines and SOPs in a cGMP environment
Perform sample analysis using HPLC
Perform maintenance of Instrument
Able to understand the applications of HPLC
Operate FTIR (Fourier Transform Infra-Red Radiation) Theory Duration 05 Days OJT Duration 25 days Corresponding NOS Code LFS/N0301
Use sampling methods for IR Spectroscopy
Explain working principle and procedure of GC
Recognize types of vibrations in IR
Explain main parts of IR spectrometer and their functions
Implement the operational parameters to be followed
Perform sample analysis using IR
Perform maintenance of Instrument
Able to understand the applications and limitation of FTIR
Operate Gas Chromatography (GC) Theory Duration 05 Days OJT Duration 25 days Corresponding NOS Code LFS/N0301
Explain types of GC namely GSC (gas solid chromatography) and GLC (gas liquid chromatography)
Explain working principle and procedure of GC
Classify the instrument components, their function and operational parameters to be followed.
Perform sample analysis using GC
Carry out maintenance of Instrument
Able to understand the applications of GC
Perform Chemical Analysis for QC Samples Theory Duration 05 Days OJT Duration 25 days
Explain qualitative and quantitative chemical analysis.
Perform qualitative tests for detection of evolved gas, formation of precipitates, limit tests, colour change reactions, melting point and boiling point test etc.
Perform quantitative analytical techniques that are mainly used to quantify any compound or substance in the sample.
Explain various types of qualitative analysis: 1.Chemical methods a) volumetric or titrimetric methods b) gravimetric methods 2.Instrumental methods
Corresponding NOS Code LFS/N0301 LFS/N0320 LFS/N0314
Summarize reference standards and working standards and their use
Identify samples for stability study
Outline the operating procedure of stability chamber used in the organization
Carry out loading and withdrawal of sample in/from stability chamber
Make use of ICH guidelines on stability testing of new drug substances and drug products, USFDA guidelines on Stability testing, CPMP guidelines on stability, WHO guidelines on stability testing of pharmaceutical products
Perform Analytical method Validation Theory Duration 05 Days OJT Duration 15 days Corresponding NOS Code LFS/N0301
Outline the need for analytical method validation.
Perform analytical method validation as per SOP
List of Assessable outcomes/assessment criteria
Assessment Criteria
Job Role Quality Control Chemist
Qualification Pack
LFS/Q1301, V1.0
Sector Skill Council
Life Sciences Sector Skill Development Council
Sr. No.
Guidelines for Assessment
1 Criteria for assessment for each Qualification Pack will be created by the
Sector Skill Council. Each Performance Criteria (PC) will be assigned
marks proportional to its importance in NOS. SSC will also lay down
proportion of marks for Theory and Skills Practical for each PC
2 The assessment for the theory part will be based on knowledge bank of
questions created by the SSC
3 Individual assessment agencies will create unique question papers for
theory part for each candidate at each examination/training center (as per
assessment criteria laid out in Qualification Pack)
4 Individual assessment agencies will create unique evaluations for skill
practical for every student at each examination/training center based on
the assessment criteria laid out in qualification pack
5 To pass the Qualification Pack, every trainee should score a minimum of
70% aggregate in all NOS and a minimum of 50% in every NOS
6 In case of successfully passing only certain number of NOS's, the trainee
is eligible to take subsequent assessment on the balance NOS's to pass
the Qualification Pack
Marks Allocation
Assessment Outcome
Assessment Criteria of outcome
Total Marks (600)
Out of
Theory Skills
Practical
1. LFS/N0301: Perform routine analysis in lab while ensuring
PC1. perform all the routine quality check activities and validations satisfactorily, including checking for sample authenticity,
100 3 1 2
compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
appropriate storage of chemicals/ reagents, maintaining reaction temperatures
PC2. train the line staff effectively to perform quality checks
5 2 3
PC3. plan and manage manpower efficiently to undertake the needed work/ quality checks, post receiving samples for testing, recording in the specified documents
6 3 3
PC4. ensure that all work meets applicable QA/QC guidelines and approved within procedures
10 5 5
PC5. review the data given by analysts and ensure that it is as per the SOP approved within procedures
10 5 5
PC6. ensure all activities conducted shall meet the quality standards and norms as specified
10 5 5
PC7. review and update test methods and procedures according to SOP approved within procedures as per schedule or when a regulatory requirement arises according to written procedures
6 3 3
PC8. fill log book, column, reagent, volumetric solution, working standard, reference standard entries, calibration records, etc and prepare reports for document findings and
6 2 4
recommendations on time
PC9. conduct sampling and analysis on time and as per approved written procedure, along with reagent, reference standard preparation and standardization
10 5 5
PC10. coordinate effectively with personnel in other disciplines to integrate findings and recommendations
4 2 2
PC11. analyze root cause of deviations, OOS/OOT and incidents, take corrective as well preventive actions to avoid future deviations
4 2 2
PC12. analyze root cause of deviations, OOS/OOT and take corrective actions
4 1 3
PC13. participate in laboratory investigations and check the validity/ stability of volumetric solutions/pH buffers, standards as part of daily routine and discard expired solutions/standards as per written procedures
4 2 2
PC14. regular documentation (online/offline) of all the activities
2 1 1
PC15. conduct regular checks for positioning of all equipment and instrument tags and undertake cleaning procedures for instruments post usage
4 2 2
PC16. conduct regular checks on equipment and
4 2 2
instrument conditions, document calibrations and coordinate with maintenance team for preventive maintenance
PC17. precision in instrument calibrations as per specified and approved schedule to minimize source of errors
4 2 2
PC18. maintain instrument maintenance logs and follow preventive maintenance schedules
2 1 1
PC19. investigate out of calibration if any, and impact of previously analyzed products as per approved written procedures
2 1 1
Total 100 47 53
2. LFS/N0101: Maintain a healthy, safe and secure working environment in the life sciences facility
PC1. observe and comply with the company’s current health, safety and security policies and procedures
100
10 5 5
PC2. while carrying out work, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines
10 5 5
PC3. report any identified breaches in health, safety, and security policies and procedures to the designated person
10 5 5
PC4. responsible for maintaining discipline at the shop-floor/ production area
10 5 5
PC5. identify and correct any hazards that the individual can deal with safely, competently and within the limits of their authority
10 5 5
PC6. adhere and comply to storage and handling guidelines for hazardous material
10 5 5
PC7. identify and recommend opportunities for improving health, safety, and security to the designated person
10 5 5
PC8. complete any health, safety and security activities like safety drills and prepare records legibly and accurately
10 4 6
PC9. report any hazards that the individual is not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected
10 4 6
PC10. follow the company’s emergency procedures promptly, calmly, and efficiently
10 5 5
Total 100 48 52
3. LFS/N0302 Coordinate with Supervisors and colleagues within and outside the department
PC1. receive work instructions from reporting supervisor
100
10 5 5
PC2. communicate to reporting supervisor about process-flow improvements, production defects received from previous process, repairs and
10 5 5
maintenance of equipment as required
PC3. communicate deviations in the production process to reporting supervisor
10 5 5
PC4. communicate any potential hazards or expected process disruptions
10 4 6
PC5. handover completed work to supervisor
10 5 5
PC6. work as a team with colleagues and share work as per their or own work load and skills
8 4 4
PC7. work and support colleagues of other departments
8 3 5
PC8. train line or reporting staff if needed
10 5 5
PC9. communicate and discuss work flow related difficulties in order to find solutions with mutual agreement
8 4 4
PC10. explain what information means and how it can be used to team members
8 4 4
PC11. document all the control steps undertaken or recommended to be followed as per the standards
8 4 4
Total 100 48 52
4. LFS/N0320:
PC1. ensure that total range of checks are regularly and consistently performed
100
16 8 8
PC2. use appropriate measuring instruments, equipment, tools,
13 5 8
To carry out quality checks in the quality control process
accessories etc., as required
PC3. ensure the status and accuracy of instruments used for measurement
10 5 5
PC4. identify non-conformities to quality assurance standards
13 5 8
PC5. identify potential causes of non-conformities to quality assurance standards
13 5 8
PC6. identify impact on final product due to non-conformance to company standards
16 8 8
PC7. evaluating the need for action to ensure that problems do not recur
6 3 3
PC8. suggest corrective action to address problem
7 3 4
PC9. review effectiveness of corrective action
6 3 3
Total 100 45 55
5. LFS/N0314: To carry out reporting and documentation to meet quality standards
PC1. report defects/problem/incidents/quality issues/test results as applicable in a timely manner
100
10 5 5
PC2. report to the appropriate authority as laid down by the company
3 1 2
PC3. follow reporting procedures as prescribed by the company
4 2 2
PC4. work with production management and Quality Assurance to provide feedback regarding quality standards and issues
4 2 2
PC5. help other R&D lab staff with any other testing required during the developmental work
4 2 2
PC6. identify documentation to be completed relating to one’s role
7 3 4
PC7. record details accurately in appropriate format
6 3 3
PC8. accurately document the results of the inspections and testing
8 4 4
PC9. maintain all controlled document files and test records in a timely and accurate manner
10 5 5
PC10. ensure that the final document meets regulatory and compliance requirements
7 2 5
PC11. make sure documents are available to all appropriate authorities to inspect
5 2 3
PC12. evaluate problems and make initial recommendations for possible corrective action to supervise
4 2 2
PC13. perform review of records and other documentation for compliance to established procedures and Good Documentation Practices
8 4 4
PC14. write and update the inspection procedures, protocols and checklists
6 2 4
PC15. prepare inspection reports as per the inspection activity performed
6 2 4
PC16. respond to requests for information in an appropriate manner whilst following organizational procedures
4 2 2
PC17. inform the appropriate authority of requests for information received
4 2 2
Total 100 45 55
6. LFS/N0103: Ensure cleanliness in the work area
PC1. inspect the area while taking into account various surfaces
100
4 2 2
PC2. identify the material requirements for cleaning the areas inspected, by considering risk, time, efficiency and type of stain
5 2 3
PC3. ensure that the cleaning equipment is in proper working condition
5 2 3
PC4. select the suitable alternatives for cleaning the areas in case the appropriate equipment and materials are not available and inform the appropriate person
4 2 2
PC5. plan the sequence for cleaning the area to avoid re-soiling clean areas and surfaces
4 2 2
PC6. Inform the affected people about the cleaning activity
4 2 2
PC7. display the appropriate signage for the work being conducted
4 2 2
PC8. ensure that there is adequate ventilation for the work being carried out
5 2 3
PC9. wear the personal protective equipment required for the cleaning method and materials being used
4 2 2
PC10. use the correct cleaning method for the work area, type of soiling and surface
4 2 2
PC11. deal with accidental damage, if any, caused while carrying out the work
4 2 2
PC12. report to the appropriate person any difficulties in carrying out work
4 2 2
PC13. identify and report to the appropriate person any additional cleaning required that is outside one’s responsibility or skill
4 2 2
PC14. ensure that there is no oily substance on the floor to avoid slippage
4 2 2
PC15. ensure that no scrap material is lying around
4 2 2
PC16. maintain and store housekeeping equipment and supplies
4 2 2
PC17. follow workplace procedures to deal with any accidental damage caused
4 2 2
during the cleaning process
PC18. ensure that, on completion of the work, the area is left clean and dry and meets requirements
4 2 2
PC19. return the equipment, materials and personal protective equipment that were used to the right places making sure they are clean, safe and securely stored
5 2 3
PC20. dispose the waste garnered from the activity in an appropriate manner
5 2 3
PC21. dispose of used and un-used solutions according to manufacturer’s instructions, and clean the equipment thoroughly
5 2 3
PC22. maintain schedules and records for housekeeping duty
5 2 3
PC23. replenish any necessary supplies or consumables
5 2 3
Total 100 46 54
Grand Total 600 600 279 321
Percentage Weightage 46% 54%
Minimum Pass Percentage to Qualify 70%
Annexure A: List of Tools and Equipment for Quality Control Chemist
S.
No.
Equipment Name
Minimum number of Equipment required (per batch of 30 trainees)
Unit Type
Is this a mandatory Equipment to be available at the Training Center (Yes/No)
Dimension/Specification /Description of the Equipment/ ANY OTHER REMARK
1 Hardness Tester
1 No. Yes Pc
2 Disintegration Testing Apparatus
1 No. Yes
3 Labelling Machine
1 No. Yes Hand Held
4 Autoclave 1 No. Yes
5 Viscometer 1 No. Yes
6 pH meter 10 No. Yes Unit= Pc
7 Bulk density and Tapped density tester
2 No. Yes
8 Friabilator 5 No. Yes Unit= Pc
9 Vernier callipers 5 No. Yes Unit= Pc
10 Micrometre screw gauge
5 No. Yes Unit= Pc
11 Scale 5 No. Yes Unit= Pc
12 Hot plate with magnetic stirrer
2 No. Yes Unit= Pc
13 UV Analyser 1 No. Yes
14 Mortar and Pestle (Type: Silica, SS-316L, Agate, Granite)
10 No. Yes Unit= Packet
15 Halogen Moisture Analyzer
1 No. Yes Unit= Pc
16 Sieve Shaker 1 No. No Unit= Pc
17 Sieve meshes (Grade level 100)
2 No. No Unit= Pc
18 Sieve meshes (Grade level 150)
2 No. No Unit= Pc
19 Sieve meshes (Grade level 200)
2 No. No Unit= Pc
20 Sieve meshes (Grade level 250)
2 No. No Unit= Pc
21 Motor grinder 4 No. Yes Unit= Pc
22 Analytical balance with printer (of different capacity and sensitivity 0.001 mg, 0.01 mg,0.1 mg,1 mg sensitivity)
2 No. Yes
23 Pipettes (1mL) 1 No. Yes Unit= Pc
24 Pipettes (2ml) 1 No. Yes Unit= Pc
25 Pipettes (5ml) 1 No. Yes Unit= Pc
26 Pipettes (10ml) 1 No. Yes Unit= Pc
27 water bath 2 No. Yes Unit= Pc
28 Dissolution Apparatus
1 No. Yes
29 Computer (including Monitor, CPU, Keyboard, typewriter, UPS)
5 No. Yes Unit- Pc
30 Microsoft Office Version 2007 and above (including Ms. Word, Ms Excel, Ms PowerPoint, Ms Outlook)
5 No. Yes Unit= Pc
31 Computer work desk with LAN
5 No. Yes Unit= Pc
32 Syringes (2 ml) 100 No. Yes Unit= Pc
33 Syringes (5 ml) 100 No. Yes Unit= Pc
34 Syringes (10 ml) 100 No. Yes Unit= Pc
35 FT-IR 1 No. Yes
36 Muffle Furnace 1 No. Yes Unit= Pc
37 Silica Crucibles 4 No. Yes Unit= Pc
38 Platinum Crucibles
2 No. Yes
39 Loss on Drying Machine with Vacuum, pressure gauge meter
1 No. No
40 Refractometer 1 No. Yes
41 Polarimeter 1 No. Yes Unit= Pc
42 Auto titrator 1 No. Yes
43 Melting Point 1 No. Yes Unit= Pc
44 Capillary tubes 100 Packet Yes Unit= Pkt
45 TLC Chamber 1 No. Yes Unit- Pc
46 Black particle size analyser
1 No. No
47 Density Meter 1 No. Yes
48 Karl Fisher Apparatus
1 No. Yes Unit=Pc
49 Particle Size Analyzer
1 No. No
50 Barcode Scanner
1 No. Yes Hand Held
51 Torque Tester 1 No. Yes
52 Induction Cap Sealer
1 No. Yes
53 Bursting strength Tester
1 No. Yes
54 Pin hole tester 1 No. Yes
55 Differential scanning calorimeter
1 No. No
56 HPLC 1 No. Yes (Make: Agilent/Waters/Shimadzu)
57 Mobile phase filtration kit with filters (MilliQ) with vacuum motor
1 No. Yes Unit= Pc
58 Milli-Q / TKA water for HPLC
10 Ltr Yes Unit= Ltr
59 Syringe Filters (6,6-Nylon, PVTF, PVDFE, PTFE etc..)
10 Packet Yes Unit= Pkt
60 Specific optical rotation Analyser
1 No. No
61 HPLC vials 10 Packet Yes Unit= Pkt
62 Crimpers 1 No. Yes Unit-= Pc
63 Dissolution filters ( 1 micron)
1 No. Yes
64 Gas chromatographer (Agilent GC6850)
1 No. Yes
65 GC vials 10 No. Yes
66 GC injection needle
5 No. Yes
67 HPLC Columns (multiple application)
3 No. Yes
68 GC Column (Glass)
1 No. Yes
69 GC Column (Capillary)
1 No. Yes
70 Sonicator 1 No. Yes
71 Hot Air Oven 1 No. Yes Unit= Pc
72 Rotary shaker 1 No. Yes Unit- Pc
73 Glassware drying oven
2 No. Yes
74 Cleaning Agent (Soap) (Ltr)
5 Ltr Yes Unit= Ltr
75 Cleaning Agent (Ltr)
5 Box Yes Unit= Box
76 Centrifuge 1 No. Yes Unit= Pc
77 Centrifuge Tubes (10ml)
50 Packet Yes Unit= Pkt
78 Centrifuge Tubes (25ml)
50 Packet Yes Unit= Pkt
79 Centrifuge Tubes (50ml)
50 Packet Yes Unit= Pkt
80 Conductivity Meter
1 No. Yes Unit= Pc
81 Magnetic Stirrer 2 No. Yes Unit= Pc
82 LOD (Loss on Drying) Bottles
10 No. Yes Unit= Pc
83 Desiccator 2 No. Yes Unit= Pc
84 Droppers 10 No. Yes Unit= Pc
85 Vortex Mixer 2 No. Yes
86 Leak Test Apparatus
1 No. Yes Unit= Pc
87 Pycno Meter 5 No. Yes Unit= Pc
88 Thermometer 5 No. Yes Unit= Pc
89 Tensile strength tester
1 No. Yes
90 Micropipette (20 to 200 microlitre)
2 No. Yes Unit= Pc
91 Micropipette (100 to 1000 microlitre)
2 No. Yes Unit= Pc
92 Micropipette (0.5 ml to 5 ml)
2 No. Yes Unit= Pc
93 Chemical Resistant Cabinet
2 No. Yes
94 Chemical spillage kit
3 Packet Yes Unit= Pkt
95 Acid Dispenser 5 No. Yes
96 Biosafety Cabinet
1 No. Yes
97 Laminar air flow (Vertical)
2 No. Yes
98 Tube heating block
2 No. Yes Unit= Pc
99 Water Filtration assembly (multi head)
2 No. Yes Unit= Pc
100 Vacuum pump 2 No. Yes Unit= Pc
101 Hot Plate 1 No. Yes Unit= Pc
102 Dry Heat Air Oven
1 No. Yes Unit= Pc
103 Depyrogenation oven
1 No. Yes Unit= Pc
104 Refrigerator 1 No. Yes Unit= Pc
105 Deep freezer 1 No. No
106 Lab incubator for different temperature range
5 No. No Unit= Pc
107 Anaerobic jar 2 No. Yes Unit= Pc
108 Gas burner 2 No. Yes Unit= Pc
109 Gas lighter 2 No. Yes Unit= Pc
110 LPG cylinder 1 No. Yes Unit= Pc
111 Shaker incubator
1 No. Yes Unit= Pc
112 Garment cubicle 2 No. No Unit= Pc
113 Sterility test apparatus (Closed system)
1 No. No
114 Needle burner 1 No. Yes Unit= Pc
115 Hygrometer 2 No. Yes Unit= Pc
116 Heat sealing machine
1 No. Yes Unit= Pc
117 TOC analyser 1 No. No
118 Particle counter 1 No. No
119 TOC Tubes 1 Packet Yes Unit=Pkt
120 Half Face Mask 4 No. Yes Unit=Pc
121 Full Face Mask 4 No. Yes Unit=Pc
122 Various Cartridges
4 No. Yes Unit=Pc
123 Safety Goggles 30 No. Yes Unit=Pc
124 Safety Shoes 4 No. Yes Unit=Pc
125 Gum Boots 1 No. Yes Unit=Pc
126 Chemical Absorbent Roll
2 No. Yes Unit=Pc
127 Self Contained Breathing Apparatus
2 No. Yes Unit=Pc
128 PVC Apron 2 No. Yes Unit=Pc
129 Gloves(Nitrile) 2 Box Yes Unit=Box
130 Gloves({Heat, acid, chemical} resistant)
2 Box Yes Unit=Box
131 Gloves(washing)
2 Box Yes Unit=Box
132 Lab Coat 30 No. Yes Unit= Pc
133 CO2 type Fire Extinguisher
2 No. Yes Unit= Pc
134 ABC Type Fire Extinguisher
2 No. Yes Unit= Pc
135 Material Safety Data Sheet
2 No. Yes Unit= Pc
136 Chemicals (Mandatory Solvents 14)
500 Milli. Ltr Yes Unit= ml
137 Formats of organization Log Books
1 No. Yes Unit= Pc
138 GLP Guidelines 5 No. Yes Unit= Pc
139 Format of organization lab Note Book
1 No. Yes Unit= Pc
140 Format of Sample preservation / processing record sheet of organization
1 No. Yes Unit= Pc
141 Glassware for Lab
1 Set Yes Unit= Set; 2 piece each estimated for a small QC/ Chemistry Lab with two fume hoods
142 White Board Duster
1 No. Yes Unit= Pc
143 White Board Marker
2 No. Yes Unit= Pc
144 Flip Charts 5 No. Yes Unit= Pc
145 Laser Pointer 1 No. No Unit= Pc
Annexure B:
Assessment Strategy for Quality Control Chemist
The assessment for the Basic Training and On the Job Training will be conducted toward
the end of the OJT duration.
Assessment Process:
The assessment will be in two parts as below:
Part 1: OJT Assessment
For OJT assessment the Industry nominated assessor will be assessing the candidates
based on the OJT monitoring report submitted by Industry supervisor and Viva by the
Industry nominated assessor
1.1 Industry nominated assessor:
The Assessors are engaged to conduct the assessments by Industry. The selection takes
place as follows
Industry defines the criteria for profile of an assessor.
Assessor is a person who is currently working in the same industry on same or
higher job role and has minimum 5-7 years of experience.
Once selected, the assessor is oriented by Industry using LSSSDC guidelines on
various aspects of the assessment and management of assessment, such as
QP and its background.
Training on Assessment methodology and how to use Assessment tools. Scoring
system. (as per the attached assessment guide)
Maintain integrity at the assessment site.
Crisis handling and support system available for the same.
Scope of his authorities
Administrative responsibilities.
Required documentation of Trainee credentials, mark sheet management.
Confidentiality management.
1.2 Assessment Tool for OJT:
1.2.1 OJT Monitoring Report:
As in Life Sciences Sector reproducing the evidence for assessment is not feasible
due to constraints like cost, confidentiality and controlled environment, every
apprentice is required to record the evidences performed during the OJT and the
same gets authorized by his/her supervisor.
The evidence recording is done in a structured monitoring report, termed as OJT
monitoring report.
During the OJT, every trainee is required to fill the OJT monitoring report which is
required to be signed by his/her supervisor.
Towards the end of OJT period these reports are submitted with the HR
department of company
These duly submitted reports are then verified by an Industry nominated assessor
for verification of evidence.
1.2.2 Viva:
Scope – Is used to test the knowledge and understanding and skills acquired during the
OJT as well as to conform the OJT monitoring report.
Some personality traits and generic skills (such as – promptness, sharpness,
communication skills, depth of knowledge, comprehension, presentation, patience etc)
can also be tested required for the QP.
Tools – Direct dialogue between assessor and Trainee.
Method – Direct questions open and close ended questions, situation-based questions,
analytical questions, and decision making based questions. Different questions are
included to test relevant PCs from the QP
Analysis – Assessor draws a spectrum of ready answers to be expected from trainee.
This reduces effect of subjectivity of the assessor. Comparative quality of trainees with in
a batch or different institutes can be gauged.
1.3 Execution of OJT Assessment:
HR department then hands over the individual OJT monitoring report with Industry
nominated assessor and schedules an assessment meeting for each trainee
Industry nominated assessor assesses each trainee based on OJT monitoring
report, viva on each PC and attendance with each trainee towards the end of the
OJT period.
The OJT marks are compiled for each NOS by the Industry nominated assessor
and submitted with HR department of company.
The OJT assessment results are then sent to LSSSDC by HR department of
company in a sealed envelope for compiling the assessment results.
Part 2: Basic Training Assessment
For Execution of the assessment for basic training, LSSSDC will be engaging more than
one assessment agencies/ body.
2.1 Criteria of selection of assessment body/agency:
The assessment body/agency is selected on the basis of
Prior experience and understanding of Life Sciences or similar sector.
Experience in conducting assessments for similar job roles.
Manpower and Technical capabilities.
Geographical reach
Existing Network in the Life Sciences Sector
Agencies internal policies to maintain standards, quality & professional Integrity
Agencies policy in assessor management
2.2 Assessment tool for Basic Training:
For the Basic training assessment, the assessment instrument development is done by
the selected assessment body with close monitoring and support of LSSSDC at every
stage.
2.2.1 Digital Written test for knowledge assessment:
Scope – Is used to test the knowledge component of the QP.
Tools –computer or tab based online or offline.
Method – objective type questions, match the columns, fill in the blanks, tick the odd man
out, choose the correct option, choose the best answer, True or false, Identify the object,
tool or machinery, arrange in proper sequence, case study, scenario-based responses.
Analysis – Question paper is divided in sections. Each Section intends to assess a
particular knowledge field of the trainee. Thus, section wise calculation of marks gives the
clear idea of the areas of improvement or expertise of the trainee. While a consolidated
mark gives the overall rating of the trainee.
2.2.2 Digital Written test for skill assessment:
Scope – Is used to test primarily the Skill component of the QP. Trainee’s expertise in
handling and managing the situation is tested.
Tools – computer or tab based online or offline questions
Method – A situation is narrated or created in the question posed to the trainee and he
is asked objective type questions to select the correct reaction to the situation. The
selected situations are based on real situations.
Analysis – Question paper is divided in sections. Each Section intends to assess a
particular skill field of the trainee. Thus, section wise calculation of marks gives the clear
idea of the areas of improvement or expertise of the trainee. While a consolidated mark
gives the overall rating of the trainee.
2.3 Steps for assessment development:
Selection of assessment tool(s) is done as per the assessment criteria prescribed
in Qualification Pack.
For Medical Sales Representative assessment a blue print of the question paper,
is part of assessment tool for basic training.
Development of lay-out of Question paper is such that the entire PCs (Performance
Criteria) of that QP are covered.
Score per question maps with the weightage given to that PC, in the assessment
criteria and the level of difficulty of the question.
An expert from industry is selected who is called “Subject Matter Expert” (SME).
This SME must have over 13-15 years of experience in the industry in sales &
marketing occupation.
SME is screened and approved by LSSSDC. He is the oriented by both LSSSDC
and Assessment agency on – creating question Bank, level of questions, end
desired outcome of the assessment.
2.4 Execution of Basic Training Assessment:
Once LSSSDC receives the OJT assessment results, the assessment date for
basic training is decided with common agreement of Industry and LSSSDC and
turn is directed to an assessment body/agency.
Assessment agency ensures the availability of required infrastructure, tools for the
assessment.
The assessment is executed in two possible ways depending on the choice of
industry:
2.4.1 Tab based assessment using physical proctoring
2.4.2 Smart phone-based assessment using e-proctoring
2.4.1 Tab-based assessment using physical proctoring
A representative from Assessment agency are present on the day of assessment
to execute the assessment at venue in case of physical proctoring.
Assessment agency representative carries an identity card and letter from the
council authorising to conduct the assessment.
Assessment agency representative ensures authenticity of Trainee’s identity by
verifying the documents (any document issued by GOI, such as Ration card,
Aadhaar Card, Driving Licence, Passport, election card etc)
Assessment agency representative maintains the records of attendance, verified
documents and tablet instruments used in assessment.
Assessment agency representative collects evidences of the assessment in best
possible way (videos, pictures, voice recordings etc)
Assessment agency representative transfer the assessment scores from tab to
assessment agency server, using a secure, encrypted web-based program.
The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days of assessment.
2.4.2 Smart phone-based assessment using e-proctoring
All trainees due for assessments are registered on a assessment tool application
using their unique mobile number and e-mail ID along with a Govt. ID issued proof.
An assessment link is sent to the mail ID of each trainee with a defined expiry date
of the link.
Trainee at any location can click on the link using his/her smart phone or a web
camera enabled computer system
Using the unique credentials and govt ID number, trainee logs in for start of
assessment and completes the assessment.
Authenticity of Trainee’s identity is done by assessment application by verifying
the documents (any document issued by GOI, such as Ration card, Aadhaar Card,
Driving Licence, Passport, election card etc.) and a live photo capture
A live video of candidate during the assessment is captured to collect the
evidences of the assessment
Once the assessment is complete, the assessment application automatically
assessment scores to assessment agency server, using a secure, encrypted web-
based program.
The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days of assessment.
Assessment Result compilation:
LSSSDC compiles the score submitted by assessment agency and OJT score
submitted by Industry HR department.
LSSSDC cross checks and validates the data and declares the result to Industry
and trainee.
Passed trainees are provided with certificate
