Environmental conditions can impact product shelf life, and the viability of product formulation.Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.
Create specifications to define the environmental monitoring criteria for the storage conditions. A monitoring or nonitem specification must be created to include tests that support each required storage condition detail such as ambient temperature, relative humidity, and atmospheric pressure. Create a specification validity rule to specify the resource or physical location to monitor. These conditions include a unique combination of temperature and relative humidity measurements that differentiate testing conditions for a stability study.The storage conditions created require the environmental monitoring of a defined equipment resource such as a refrigerator or a subinventory locator in a particular storage organization.The planned and actual storage condition parameters must be monitored for each storage condition combination.For example, 30 deg C/60% RH requires the monitoring of both the 30 deg C refrigeration and 60% RH ambient moisture content.Results of testing on these materials provide valuable information about overall product stability, and serve as a basis for product claims on storage requirements and shelf life. Food & Drug Administration (FDA) provides compliance guidelines for drugs and medical devices.
There are a number of key national and international standards, laws, regulations, and guidelines for Good Manufacturing Practice (c GMP). The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a consortium of regulatory authorities from Europe, Japan, the United States, and experts from the pharmaceutical industry worldwide.
Set up document numbering using the Samples tab in the Process Quality Parameters window for the organization where you plan to perform the sampling.
Set up document numbering using the Stability Studies tab in the Process Quality Parameters window for the stability study organization.
This topic provides procedures for creating and managing stability studies including when they are performed, and what essential guidelines exist for stability testing programs.
The topic also provides an overview of the stability study lifecycle management, including the creation of test interval plans and the creation of a storage condition plan.
21 CFR,211 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 211.1 Scope.211.3 Definitions.211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants.211.42 Design and construction features.211.44 Lighting.211.46 Ventilation, air filtration, air heating and cooling.211.48 Plumbing.211.50 Sewage and refuse.211.52 Washing and toilet facilities.211.56 Sanitation.211.58 Maintenance.211.63 Equipment design, size, and location.211.65 Equipment construction.211.67 Equipment cleaning and maintenance.211.68 Automatic, mechanical, and electronic equipment.211.72 Filters.211.80 General requirements.211.82 Receipt and storage of untested components, drug product containers, and closures.211.84 Testing and approval or rejection of components, drug product containers, and closures.211.86 Use of approved components, drug product containers, and closures.211.87 Retesting of approved components, drug product containers, and closures.211.89 Rejected components, drug product containers, and closures.211.94 Drug product containers and closures.211.100 Written procedures; deviations.211.101 Charge-in of components.211.103 Calculation of yield.211.105 Equipment identification.211.110 Sampling and testing of in-process materials and drug products.211.111 Time limitations on production.211.113 Control of microbiological contamination.211.115 Reprocessing.211.122 Materials examination and usage criteria.211.125 Labeling issuance.211.130 Packaging and labeling operations.211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.211.134 Drug product inspection.211.137 Expiration dating.211.142 Warehousing procedures.211.150 Distribution procedures.211.160 General requirements.211.165 Testing and release for distribution.211.166 Stability testing.211.167 Special testing requirements.211.170 Reserve samples.211.173 Laboratory animals.211.176 Penicillin contamination.211.180 General requirements.211.182 Equipment cleaning and use log.211.184 Component, drug product container, closure, and labeling records.211.186 Master production and control records.211.188 Batch production and control records.211.192 Production record review.211.194 Laboratory records.211.196 Distribution records.211.198 Complaint files.211.204 Returned drug products.211.208 Drug product salvaging.