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QUALITY CONTROL LABORATORY REQUIREMENTS
PRESENTED BY: PATRICK OWUSU-DANSO
(LSD)
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OUTLINE• INTRODUCTION
• LABORATORY REQUIREMENTS FOR REGISTRATION OF PRODUCT• Key Documents• Key Lab tests
• LABORATORY REQUIREMENTS FOR GMP• Premises• Sampling and Testing• Equipment• Reporting of Test report• Personnel• Documentation
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INTRODUCTION• A quality assurance program for extemporaneous preparations should
include testing during the manufacturing process and of the finished product.
• A basic understanding of pharmaceutical analysis is required to ensure that valid results are obtained when tests are being conducted, whether they are done in-house or outsourced.
• The goal in testing is to determine accurately the adequacy of the process and the quality of the finished product.
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Lab requirements for product registration-key documents
• Submission of Specifications for Finished product.
• Submission of Certificate of Analyses of finished product.
• Products that have monographs in Officially Recognized Pharmacopoeia shall be tested as per the procedure in the pharmacopoeia.
• Submission of analytical procedure along with validation protocol and report for non-compendial products.
• Submission of samples for testing.
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Key Laboratory tests for product registration
• CALAMINE LOTION BP
• Description/Appearance
• Identification test (Test A; Color reaction Silver mirror test & Test B: test for Zinc salts)
• Residue on Ignition
• MIST MAGNESIUM TRISILICATE BP
• Description/Appearance
• Identification test (Test A: Test for Bicarbonates, Test B: Test for magnesium, Tests C: Test for Carbonates, Test D: Tests for Silicates)
• Acid Neutralizing Capacity
• Assay (Magnesium and Sodium Bicarbonate)
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Key Laboratory tests for product registration
• MIST POTASSIUM CITRATE BP
• Description/Appearance
• Identification (Test A: Potassium, Test B: Citrates)
• KAOLINE MIXTURE BP
• Description/Appearance
• Identification (Test for Magnesium & Carbonates)
• Assay (Magnesium & Sodium Bicarbonate)
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Key Laboratory tests for product registration
• SIMPLE LINCTUS BP
• Description/Appearance
• Identification
• Assay
• POVIDONE IODINE SOLUTION BP
• Description/Appearance
• Identification (Color reaction tests)
• pH
• Assay (Content of Available iodine & Content of Iodide)
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Key Laboratory tests for product registration• METHYLATED SPIRIT BP
• Description/Appearance
• Identification (Color reaction Test)
• Acidity and Alkalinity
• Clarity of solution
• Apparent density
• HYDROGEN PEROXIDE BP
• Description/Appearance
• Identification
• Acidity
• Assay
❖Microbial Limit Tests shall also be performed based on the Product.21/01/19 WORKING FOR YOUR SAFETY 8
Laboratory requirements for GMP
Questions to consider:
• Should all testing activities be performed by manufacturer.?
• Should some tests be performed by manufacturer and others subcontracted.?
• Should all testing activities be subcontracted.?
• What about relevant in-process tests.?
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KEY CONSIDERATIONS -GMP
• Premises
• Sampling Requirements
• When to test?
• What Parameters to test?
• What appropriate method(s) and equipment to use?
• Reporting of the results
• Specific actions required when a preparation does not meet specifications
• Personnel Requirements and Considerations
• Documentation
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KEY CONSIDERATIONS- 1. PREMISES• Suitable size, construction and location – appropriate for the functions and
operations.
• Instruments and equipment, work benches, work stations and fume hoods.
• Adequate safety equipment and good housekeeping.
• Environmental conditions (temperature, humidity) - monitored, controlled and documented.
• Storage facilities for samples, retained samples, reagents and laboratory accessories, reference substances and reference materials.
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KEY CONSIDERATIONS- PREMISES
• DO WE NEED A FACILITY LIKE THIS for extemporaneous products?????????
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KEY CONSIDERATIONS- Sampling Requirements
• Appropriate sampling procedure for obtaining representative samples.
• Number of samples needed.
• Type of container required for collection and storage.
• Any special handling in transit to testing laboratory.
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KEY CONSIDERATIONS- When to test?
• Before manufacturing ( i.e. Active ingredients and excipients)?
• During manufacturing (In-process test for key intermediates)?
• At the of manufacturing ( Finished preparation)?
• Other components (Purified water)?
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KEY CONSIDERATIONS- What appropriate method(s) to use
• One general consideration in testing procedure selection is the type of information needed, such as quantitative (strength, concentration), semiquantitative or qualitative (presence/absence testing, including substance identification.
• Pharmacopoeia Method.
• Validated In-house Method.
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Equipment for testing
Include but not limited to the following:
• Analytical Balance
• pH Meter
• Oven
• Mechanical Shaker
• Hot Plate/ Magnetic Stirrer
• Water Treatment Apparatus
• UV spectrophotometer
• Volumetric Glassware( Burette, pipette etc.)
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KEY CONSIDERATIONS - Equipment for testing• Unique identification (number) for equipment, instruments,
devices used for testing, verification and/or calibration.
• Also labels indicating status of calibration and due date.
• Work Instructions/Log book should be in place for each instrument.
• pH meters to be verified with standard certified buffer solution before use.
• Balances calibrated annually, verified daily, and regularly checked with test weights.
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KEY CONSIDERATIONS - Reporting of the results• All test results recorded, reviewed and evaluated (statistically where
necessary) – check that they are consistent and meeting specifications –signed by analyst and supervisor
Content of the analytical test report
• Sample registration number and laboratory test report number
• Name and address of the laboratory
• Name, description, batch number of the sample
• Reference to the specifications and procedures used, limits
• Testing start and completion dates, Results
• Conclusion, compliance with specification
• Signatures ( Authorized person/Supervisor)21/01/19 WORKING FOR YOUR SAFETY 18
Investigation of OOS Results
• Approved SOP for investigation of OOS results.
• Checks may include (not limited to):
• Appropriate procedures applied and followed correctly
• Discrepancies in raw data; calculations correct
• Qualified, calibrated equipment used; system suitability tests were done and acceptable
• Glassware, reagents, solvents and reference substances used
• Original sample kept until the investigation is complete
• Investigations and their conclusions recorded
• CAPA recorded
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Personnel Requirements and Considerations
• If testing is done in-house, personnel involved in this activity must be appropriately trained and evaluated with documentation of the training.
• If testing is outsourced, the compounder/manufacturer must be assured of the credentials, proper training, and continuing competency activities of the personnel in the contract laboratory.
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DOCUMENTATION
• Strict conformance to good documentation practices to assure the validity and integrity of laboratory data.
• Laboratory Notebooks/Work sheets for analyst.
• Equipment Logbooks.
• Approved SOPs and Work instructions.
• Provision of reference books (BP, USP, etc.)
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