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QUALITY CONTROL LABORATORY REQUIREMENTS

PRESENTED BY: PATRICK OWUSU-DANSO

(LSD)

21/01/19 WORKING FOR YOUR SAFETY 1

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


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.


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.


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


• 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)



• MIST POTASSIUM CITRATE BP


• Identification (Test A: Potassium, Test B: Citrates)

• KAOLINE MIXTURE BP


• Identification (Test for Magnesium & Carbonates)

• Assay (Magnesium & Sodium Bicarbonate)



• SIMPLE LINCTUS BP


• Identification

• Assay

• POVIDONE IODINE SOLUTION BP


• Identification (Color reaction tests)

• pH

• Assay (Content of Available iodine & Content of Iodide)


Key Laboratory tests for product registration• METHYLATED SPIRIT BP


• Identification (Color reaction Test)

• Acidity and Alkalinity

• Clarity of solution

• Apparent density

• HYDROGEN PEROXIDE BP


• 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.?


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


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.


KEY CONSIDERATIONS- PREMISES

• DO WE NEED A FACILITY LIKE THIS for extemporaneous products?????????


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.


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)?


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.


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.)


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.


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


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.


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.)


END

THANK YOU
