GMP

AWARENESS MODULE

What is GMP ?GMP takes the holistic approach of regulating the manufacturing

and laboratory testing environment itself.

An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems.

Additionally it is a GMP requirement that all manufacturing and testing equipment and utilities have been qualified as suitable for use

All operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the mfg. process have been validated to demonstrate that they can perform the activities they purport to, according to predetermined specifications.

GMP is designed to help assure the quality of products by ensuring several key attributes:

Including correctness and legibility of recorded manufacturing and control documentation.

Transferring data must be done in specific ways to avoid mistakes –

Such as writing down a reading on a balance/burette, Requiring a second person to also check the reading to

assure accuracy.

Methods have been developed to make this process easier

GMP- Aims At Developing Systems ,Which Are Self Sustaining and to Take Care Of :

Product ContaminationHousekeepingSanitization / Cleanliness/ Pest control/ Maintenance.Documentation Involvement Of People At All LevelsSelf Improvement Programme

GMP Objective To Prevent Or Eliminate Error At Each Stage Of

Production.

To Take All Necessary Precautions

To Ensure That We Manufacture Products Of The Required High Quality.

To Reduce Disorder In The System.

To Show Concern For The Product & The People.

Why GMP Audit? It Helps In Improving The System.

It Highlights The Weaknesses In The System.

It Helps As A Checklist To Improve Product Quality.

It Helps In Identifying Problem Areas.

It Helps For Continuous Improvement.

It Helps To Check The Implementation Of The Measures In

The Organisation.

It Helps To Find Out The Effectiveness Of The System.

It Acts As Valuable Tool To Control The Process.

1. Leadership

2. Training

3. Design, Construction & Installation

4. Formula Cards, Specifications & Standards

5. Written Procedures

6. Validation

7. Housekeeping, Pest control, Sanitization &

Maintenance

8. Starting Materials

9. Making Operations

10.Packing Operations

11.Storage & Handling of Finished Product.

12.Laboratory control

13.Process control

14.In-process & Finished Product Release & control

15.Records

16.Self Improvement Program

17.Complaints

18.Quality System Results Tracking & improvement

19.Accountability for contractors

ACT CHECK

DOPLAN

PLAN

Leadership

Training

Design, Construction & Installation

Formula Cards, Specifications & Standards

Written Procedures

DO

Validation

Housekeeping, Pest control, Sanitization &

Maintenance

Starting Materials

Making Operations

Packing Operations

Storage & Handling of Finished Product.

CHECK

Laboratory control

Process control

In-process & Finished Product Release & control

Records

Self Improvement Program

Complaints

Quality System Results Tracking & improvement

ACT

Accountability for contractors

•Senior Site Management Must Give Personal Leadership & Define Requirements to Encourage Quality Culture.

•Individuals & Teams Should Be Judged & Rewarded for Delivering Quality Product On Time As Well As Preventing Non Quality.

- MISSION STATEMENT / QUALITY POLICY- GOAL STATEMENT

- IT IS COMMUNICATED & IN PLACE- LEADERSHIP BEHAVIOURS.

KE No. 1 LEADERSHIP

KE No. 2 TRAINING

All Facilities Must Be Staffed With Sufficient Number Of Trained & Qualified Personnel To Ensure That Quality Product Is Produced & Distributed . The Training Should Be Job Specific & Include The Relevant Details Of Quality Assurance & Corporate Policies.All Training Programmes Must Have A Built In Qualification Process To Determine The Extent Of Learning.

GENERAL PRINCIPLES.QUALITY ASSURANCE & GMP

JOB SPECIFIC STATISTICAL

TOTAL QUALITY

KE No.3 DESIGN ONSTRUCTION & INSTALLATION

All New Buildings & Equipment's Should Be Designed

To Encourage Compliance With Good Quality

Procedures.

Layout Should Provide Sufficient Space & Direct

Product Flow To Help Prevent Fix Ups.

Design & Construction Should Facilitate Easy

Cleaning , Sanitization , Preventive Maintenance , &

Offer Protection From Weather , Pests & Other

Sources Of Contamination

Existing Buildings & Equipment's Must Either Comply With These Design Criteria Or Have Validated Procedures To Compensate For Design Deficiencies.

GENERAL PRINCIPLES . PREMISES

MAKING & PACKING EQUIPMENT WATER TREATMENT SYSTEM

LABORATORIES STORAGE AREAS

KE No. 4 FORMULA CARDS , SPECIFICATIONS & STANDARDS Formula Cards , Specifications & Standards Form The

Foundation Of Quality System .

Proper Finished Product & Operating Limits Must Be Set

To Ensure Good Consumer Satisfaction & Compliance With

Corporate & Regulatory Requirements.

Once Proper Limits Are Set, They Must Be Rigorously

Followed.

Systems Must Be In Place To Ensure That Only Up To Date Specifications And Standards Are In Use.

a) FORMULA CARD SYSTEM

b) RAW MATERIAL SPECIFICATIONS.

c) PACKING MATERIAL SPECIFICATIONS.

d) TEST METHODS ( ANALYTICAL ,

MICROBIOLOGICAL , & PACKAGING )

e) STABILITY TESTING & EXPIRATION DATING

SYSTEM

KE No. 5 WRITTEN PROCEDURES

To Achieve Consistency Of Product , Work Processes

Must Be Reproducible Time After Time.

A Key To Achieving This Reproducibility Is Well

Written & Rigorously Followed Procedures.

Systems Must Be In Place To Ensure That Only Up-To-

Date Procedures Are In Use.

KE No. 6 VALIDATIONAll products & analytical methods & all key processes,

production systems & procedure must be

appropriately validated to ensure they are capable of

consistently achieving their desired results.

Each business unit must have an SOP specifying

which processes & procedures require validation , &

the nature & scale of validation which is appropriate

for that business

KE No. 7 HOUSEKEEPING PESTCONTROL SANITIZATION & PREVENTIVE MAINTENANCE

All potential sources of contamination, whether biological,

chemical or physical, must be identified and controlled.

The front line of defence is always good (basic

housekeeping and maintenance).

Where products are susceptible to microbial

contamination, regular microbiological monitoring must

be carried out.

KE No. 8 STARTING MATERIALSThe quality of raw materials, packing materials and

components is important to the final quality and integrity of our products.

Starting materials must be purchased from approved suppliers according to approved specifications.

Starting materials must be effectively controlled upon receipt, during storage and in use.a) GENERAL PRINCIPLES.b) RAW MATERIALS & PACKAGING MATERIALS.c) PROCESS WATER.d) LABELS & PRINTED MATERIALS.e) OTHER PRODUCT CONTACT MATERIALS.

KE No. 9 MAKING OPERATIONSThe quality of the making operation will largely

determine the quality of the final product.Our making operations will consistently produce high

quality product when they take approved starting materials and convert them into finished product using properly specified procedures and equipment.a) PEOPLE b) EQUIPMENTc) MAKING OPERATIONSd) BLENDING & REWORK PROCEDURES ANDe) ENVIRONMENTAL CONSIDERATION

KE No. 10 PACKING OPERATIONS

Effective package design & packing line execution will establish

A positive in -store appearance impression & adequate product protection for our brands.

Code dating & expiration dating operations are critical for product traceability & in some cases , for meeting legal requirements .

Our packing operations will consistently produce high quality packages when approved starting materials are converted into finished packages using properly specified procedures & equipment.

KE No. 11 STORAGE HANDLING OF FINISHED PRODUCTEffective handling & distribution operations will help

ensure high quality product & consumer satisfaction by preventing product damage due to the environment, improper handling or excessively long storage periods.

They can also ensure high customer satisfaction with orders shipped complete as ordered , delivered on time , damage free with correct invoices.

a) STORAGE & HANDLING.b) PRODUCTS RETURNED FROM TRADE.c) SANITATION.d) INVENTORY MANAGEMENT

KE No. 12 LABORATORY CONTROLS

Professionals laboratory operations are critical to the successful control of product development activitiesa) EQUIPMENT.b) METHODS & PROCEDURES. c) SENSORY EVALUATION.d) REAGENT CHEMICALS & MEDIA.e) RECORD KEEPING & DOCUMENTATION.f) MEASUREMENT VERIFICATION SYSTEM.g) HANDLING OF OUT OF SPECIFICATION

RESULTS

KE No. 13 PROCESS CONTROLEffective process control will enable us to consistently

deliver high quality product at the lowest possible cost statistical process continues to run at target settings to minimise the cost due to scrapping & downtime.

a) CONTROL METHODOLOGY.b) PROCESS CONTROL STRATEGY.c) CENTRELINE/ SETPOINT/ FORMULATION CONTROL SYSTEM.d) ONGOING VERIFICATION OF AUTOMATIC PROCESS CONTROL.e) CONTROL OF BATCH & CONTINUOUS PROCESSING.

KE No. 14 IN PROCESS CONTROL & FINISHED PRODUCT RELEASE & CONTROL To ensure that only quality products are delivered to our

customers, good control must be established over the release of product , shipping practices, inventory control & returned goods.

There must be a system for handling deviations. There must have also be a system for retrieving product in case a serious problem is identified after a product has been shipped.a) IN PROCESS RELEASE SYSTEM.

b) RELEASE FOR SHIPMENT SYSTEM.c) HANDLING FINISHED PRODUCT DEVIATIONS.d) STATUS CONTROL / HOLD SYSTEMS / DISPOSITIONS.e) DISPOSAL OF SCRAP PRODUCT & MATERIALS.f) TRACEABILITY & RETRIEVAL.

KE No. 15 Records Thorough documentation is good science & makes good business

sense & for some business, may be a legal requirement.

Records enable us to investigate complaints, make product

improvements, & maintain ability to retrieve product should that

ever be necessary.

a) MATERIAL RECORDS.

b) EQUIPMENT RECORDS.

c) MAKING & PACKING RECORDS.

d) LABORATORY RECORDS.

e ) OTHER RECORDS.

KE No. 16 SELF IMPROVEMENT PROGRAMME Self improvement programme represent one of the most

effective tools in the company to ensure compliance with

corporate & government requirements.

a) PARTICIPATION .

b) AUDIT PROCESS

c) IMPROVEMENT & PLANNING

d) EXECUTION & TRACKING.

KE No. 17 COMPLAINTS Customer & consumer complaints are a significant source of

information concerning the designed & perceived

performance of our products.

It is essential that all information received is recorded

accurately in the complaint system and acted upon promptly

.

Complaints can be also be an important source of product

improvement ideas.

a) COMPLAINT SYSTEM

b) INVESTIGATION AND ACTION

KE No. 18 QUALITY SYSTEMS RESULT TRACKING & IMPROVEMENTS

Measurement & tracking of results is a key total quality

principle .

We must know how our systems are performing so that we

can set priorities improvement efforts.

a) GENERAL PRINCIPLES.

b) QUALITY ASSURANCE AUDITS.

c) QUALITY INCIDENTS.

d) PRODUCT QUALITY RELIABILITY.

KE No. 19 ACCOUNTABILITY FOR CONTRACTORS

Godrej’s quality expectations of our contractors joint ventures

& licences are no different from our expectations of our own

facilities.

a) CONTRACTOR SELECTION SYSTEMS.

b) CONTRACTOR ON GOING PRODUCTION

PERFORMANCE.

Thank you!