WHO - PSM
Documentation –Part 2
Workshop onGMP and Quality Assurance of TB products
Kuala LumpurMalaysia, 21 – 25 February 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: [email protected]
Basic Principles of GMP
Part One, 15
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Documentation
Question no 7
What would provide you substantial information at glance?
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Part One, 15.10–15.12
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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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Part One, 15.13–15.21
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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, 15.22–15.25
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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
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Part One, 15.22–15.24
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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.
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Part One, 15.22–15.24
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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)
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Part One, 15.22–15.24
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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
WHO - PSM
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
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Part One, 15.28–15.30
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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
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Part One, 15.28–15.30
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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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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
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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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Documentation
Question no 8
What do the letters SOP mean?
WHO - PSM
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
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Question no 9
What is the situation when documentation is needed very very very much. And information has to be found in the documents very quickly to take actions as rapidly as possible.
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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
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Conclusion
“If there is no documentation, there work has not been carried out!!!”
Everything has to be documented, right?