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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.

Link: Please click here for the current version 21CFR, part 210Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 Status of current good manufacturing practice regulations.210.2 Applicability of current good manufacturing practice regulations.210.3 Definitions.

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.

This approach provides an extensive profile of material stability at a variety of temperatures and relative humidities.

The following is an example of this type of study: Oracle Process Manufacturing (OPM) Quality Management stability studies let you create both simple and robust stability studies.

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Early stages of stability testing are typically performed on laboratory materials to determine if the material to be produced has any inherent sensitivities to storage or shipping environments.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.