WHO - PSM

Documentation –Part 2

Pharmaceutical Quality, Good manufacturing Practice &

BioequivalenceKiev, Ukraine

3 - 7 October 2005

Maija Hietava M.Sci.Pharm

Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster

Tel: +41.22.791.3598 Fax: +41.22.791.4730World Health Organization

E-mail: hietavam@who.int

Basic Principles of GMP

Part One, 15

WHO - PSM

Part One, 15.10–15.12

Documentation

Labels What must be labelled?

Containers, equipment, premises, products, intermediates, samples, standards etc.

Status (quarantined, accepted, rejected, clean) What must be on the label?

Company internal system Final products: national or multinational system

Who has responsibility for labelling? QC and production for status labels Final product, intermediates, reagents etc.

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Documentation

WHO - PSM

Part One, 15.13–15.21

Documentation

Specifications and Test Procedures

Starting and packaging materials

Intermediates and bulk products

Finished products

Specifications: approved and dated by authorised persons

Test procedures: validated or verified for reliability and consistency

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Documentation

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Documentation- batch record

Easy reading

Well designed by careful setting of blocks

Systematic approach of information

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Part One, 15.22–15.24

Documentation

Master Formulae I

Manufacturing instructions Name of product with product reference

code Dosage form, strength and batch size Full list of materials including quantities;

unique reference code Expected final yield with acceptable limits

(+intermediate yields) Processing location and principle equipment

WHO - PSM

Part One, 15.22–15.24

Documentation

Master Formulae II

Manufacturing instructions - continued

Equipment preparation methodology Stepwise processing instructionsDetails of in-process controls with

instructions for sampling and acceptance limits

Storage requirements and special precautions.

WHO - PSM

Part One, 15.22–15.24

Documentation

Master Formulae III

Packing instructions

Name of the productDosage form, strength and method of

administrationPack size (number, weight or volume of

product in finished pack)List of all packaging materials

(quantities, size and code number)

WHO - PSM

Part One, 15.22–15.24

Documentation

Master Formulae - IV Packing instructions - continued

Examples of printed packaging materials, with location of batching information

Special precautions, including area clearance checks

Description of the packaging operation In-process control checks, with sampling

instructions and acceptance criteria

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Documentation

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Part One, 15.25–15.27

DocumentationBatch Processing Records - I

Name of the product, batch number

Dates and times for major steps in process

Name of person responsible for each stage of production

Name of operators carrying out each step (check signatures)

Theoretical quantities for materials in the batch

Reference number and quantity of materials used in the batch

WHO - PSM

Part One, 15.25–15.27

DocumentationBatch Processing Records - II

Main processing steps and key equipment In-process controls carried out, and results

obtained Yield at each stage with comments on

deviations Expected final yield with acceptable limits Comments on any deviations from process. Area clearance check, instructions to

operators Record of activities

WHO - PSM

Part One, 15.28–15.30

Documentation

Batch Packaging Records - III Name of the product, batch number and

quantity to be packed Batch number, theoretical quantity and actual

quantity of finished product Reconciliation calculations, dates and times of

operation Name of person responsible for packaging,

initials of operators carrying out each step Checks made and results obtained

WHO - PSM

Part One, 15.28–15.30

Documentation

Batch Packaging Records - IV Details of packaging operation, including

equipment and line used Returns to store Specimen of printed packaging materials, with

batch coding Comments on deviations from the process and

actions taken Reconciliation of packaging materials, including

returns and destruction Area clearance check Product variables Record of activities and check signatures

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Documentation

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Documentation

Standard Operating Procedures - I

Who is responsible for SOPs? Writer, supervisor, manager, QA Writing, checking, approval

Where should SOPs be stored? Master copies – responsible department Authorised copies: working place Non-valid copies and non-valid master

copies ; wherePart One, 15.31–15.48

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Standard Operating Procedures - II

Which activities require SOPs? Receipt of all material deliveries Internal labelling, quarantine and storage of

materials Operation, maintenance and cleaning of all

instruments and equipment Sampling of materials Batch numbering systems Material testing at all stages of production

Part One, 15.31–15.48

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Documentation

Standard Operating Procedures - III Which activities require SOPs? - continued

Batch release or rejection. Maintenance of distribution records Equipment assembly and validation Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation Personnel recruitment, training,

clothing and hygiene Environmental monitoring

Part One, 15.31–15.48

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DocumentationStock Control and Distribution Records

What should be recorded? Essential information needed for traceability to the

manufacturer and supplier information of the material and the date of arrival PRODUCT RECALL

Stock Control: Batch numbers, status, quantities, expiry date etc., FIFO, EEFO (earliest to expire, first out)

Distribution records: batch number, quantity and destination of each delivery

Inventory: validation of the stock records Where should records be stored?

Easily available Why are the records important?

Traceability and status of materials

Part One, 15. 1–15.9

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Documentation

Water Quality Manual

Full details of design of system, operation and maintenance Supplier manuals can be used with internal

procedures Details of testing requirements

Microbiological Chemical