LEGAL REQUIREMENTS FOR STABILITY

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1 BY DR. A.V.PRABHU

2 LEGAL REQUIREMENTS FOR STABILITY 21 CFR STABILITY TESTING GMP To assess stability characteristics to determine storage conditions and expiration dates. Written stability program includes sample size, test interval, storage conditions, specific methods and container closure. 21 CFR (d): Content of Format Drug substance and Drug Product stability Stability Specifications and Analytical Methods Stability Data and proposed expiration

3 WHY STABILITY? Provide evidence on how the quality of a drug / drug product varies with time under the influence of a variety of environmental factors like 1.Temperature 2.Humidity 3.Light Establishes Retest period for the drug substance Shelf life for the drug product Recommend a storage conditions Because physical, chemical or microbiological changes might impact the efficiency or security of the final product.

4 STABILITY Stability studies are performed on Drug Substances / API / BPC Drug Product or Dosage Forms And Represents Controlled and documented determinations of acceptable changes to Drug Substances / Drug Products

5 STABILITY What are Physical Changes Appearance Melting Point Clarity and colour of solution Crystal modification (Polymorphism) What are Chemical Changes? Increase in Degradation Product Decrease of Assay What are microbial changes? Growth of Microorganism

6 SIGNIFICANT CHANGES DURING STABILITY A 5 % change in Assay from its initial value Any degradation product exceeding its acceptance criteria Failure to meet the acceptance criteria for Appearance, Physical attributes and functionality test (e.g. Colour, phase separation, hardness) As appropriate for the dosage form Dissolution specification for release of stability must be same (may affect Bio Equivalence)

7 CAUTION The Assay value is still within limit but the change during stability is more than 5.0 % Release Assay Limit 95.0 to 103 % Stability Assay Limit 92.5 to % Release Assay % 24 month Assay 93.0 % Loss in Potency 8.0 % THIS IS A SIGNIFICANT CHANGE

8 WHAT IS A RETEST PERIOD? The period of time during which API is expected to remain within its specifications and therefore can be used in the manufacture of a given Drug Product. Provided the API is stored under defined storage condition After this period, a batch of API destined for use in the Drug product, should be retested for compliance with the specifications and used immediately. A batch of API can be retested multiple times and a different portion of the batch used after each retest as long as it continues to comply with specifications.

9 EXPIRY / EXPIRATION DATE The date placed on the container label of a DS /DP designating the time prior to which a batch of DS/DP is expected to remain within the approved shelf life specification under defined storage conditions No retesting is permitted beyond expiration date and the DS / DP must not be used

10 WHAT ARE STABILITY INDICATING METHOD They are validated, quantitative test methods that can detect changes with time in the chemical, physical or microbiological properties of Drug Substance or Drug Product They are specific, so that the quantity of Active products and other components of interest can be accurately measured without interference in the material tested. The ability to differentiate the Active ingredients from closely related process and degradative impurities is usually the single most important requirement for stability indicating methodology.

11 WHY ARE STABILITYINDICATING METHOD NECESSARY The GMP requires a formal written stability testing program whose results are used to establish storage conditions, expiration dates of Drug Products / Substances and further mandates the use of reliable, meaningful and specific test methods

12 WHEN ARE STABILITYINDICATING ANALYTICAL METHOD NECESSARY The use of such methods is appropriate when there is an intention to document Drug product stability. These data are used to establish, conform or extend retest intervals or expiration dating periods for Drug Substance / Drug Product

13 WHAT IS THE ROLE OF QA IN DEVELOPMENT There is a need for an energized Quality Assurance function that promotes changes and uses teams to handle new regulatory challenges and exploit technological opportunities. By turning Quality Assurance into a self challenging, manufacturing science promoting organization, a true value will be added to its traditional mission of guaranteeing that quality products are put in market place and also realigning quality objectives with customer expectations.

14 WHERE DOES THE QA ROLE BEGIN? Bring Quality and manufacturing into the development process as early possible. It helps ensure that the process are carried out in a controlled documented way, thus facilitating Technology Transfer and expediting launching of new products

15 WHAT IS THE QA ROLE IN TECHNOLOGY TRANSFER Raw Material specification and method of analysis In-process specifications Standard Operating Procedures Development Batch Records Manufacturing Batch Records Deviation Reports Investigation Reports and CAPA Stability Protocols Validation Reports Stability Data Reports Assay Method Development and Transfer Reports and Associated Training Documents Manufacturing Summary Reports for Submissions Development History Reports Final Product Specifications- Rationale Testing Monographs Training Records

16 A TYPICAL STABILITY PROTOCOL / REPORT Information on batches tested (Commercial formula) Unit Composition Container Closure System Analytical methods Stability Plan or Schedules Tabulated Test Results Analysis / Discussions of Data ( Statistical negative trends) Shelf Life Proposed or Retest Literature and/or Supporting Data

17 WHERE DOES QA ROLE IN STABILITY BEGIN? Development Pharmaceutics Analytical Method Validation LOD & LOQ Right Primary Standards Including Impurities Equipment Validation especially stability ovens OOS/OOT Investigations and reporting Training Stability Packaging

18 WHAT ARE MOST FREQUENT 483 s OBSERVATIONS ON STABILITY Failure to Establish Stability Procedures and Expiration Dates Expiration Dating not Supported By Data Failure to Follow Established Stability Protocols Failure to Use or Validate Stability Indicating Methods Stability Protocols not signed by Quality Unit Stability Samples were not Representating of current Formulations No Qualification Data for Stability Chambers No Investigation and Documentation of OOS No Shipping Records for Stability Samples, Lots Not Traceable.

19 RISK/FAILURES Oven Failures-- Alarm, standyby compressors Heat Distribution No Proper Log Book Entries No Pack Simulation Sample analysis beyond point Reference / Primary Standards, Solution Stability

20

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