2. IPEC Excipient Stability Guidelines 112 Chapter 6 Stability Testing of Biological/Biotechnologial Products115 1. Introduction 115 2. ICH Q5C 116 3. Considerations for Stability Evaluation of Vaccines 124 Chapter 7 Stability of Cosmetic Products 133 1. Introduction 133 2. Colipa Guidelines 135 3. Stability of Cosmetic Products 140 Appendices Governmental Guidelines For Cosmetic Stability Testing April 10th, 2012 - Stability Testing Design A Cosmetic Stability Test Should Be Designed To Assure Stability And Physical Integrity Of Cosmetic Products Under Appropriate Conditions Of Storage Transport And Use Chemical Stability Microbiological Stability The Compatibility Between The Conten (45) In addition, another document, Cosmetics Europe, details the COLIPA guidelines to ensure that new or modified products meet physical, chemical and microbiological quality requirements, as This guideline can be used as an aid to conduct the required stability testing. The agency advises that this final guideline represents its current position on the development of The fast cycl e time for cosmetic products means that while confirmatory studies are continued a well-designed study should use experience and scientific expertise to answer the key questions about product stability. • Consider existing data on similar products with similar packaging. Colipa/CTFA Guidelines on Stability Testing of Cosmetic Products, March 2004 [8] WHO. Guidelines on Stability Testing of Pharmaceutical Products. WHO Technical Report Series. World Health Organization [9] PCPC. Guideline for Industry - The Stability Testing of Cosmetics. Personal Care Products Council (PCPC): Washington D.C.: s.n., 2011 [10] The guideline presented herein supplements both the preceding general document on stability testing prepared jointly between CTFA and Colipa in 2004, and the updated Colipa annex to that general document.

This guideline is intended to provide a resource for manufacturers in the development of a stability testing program. Following are the guidelines for stability study conduction for new products: 1. Formal stability study should consist of accelerated and long term stability testing on at least two primary production batches for stable drug products and in case of the susceptible drug products at least three primary production batches should be considered. This method has been published as a COLIPA guideline, used currently in European geographies for testing and labelling sunscreen products. This article summarizes two 'ring' studies, involving Stability testing may be of sufficient duration to cover storage, shipment and subsequent use, and to guarantee safety and quality. Manufacturers may, for each formula type, select the pertinent test criteria according to their experience and evaluate these test criteria at one or more temperatures. The purpose of a stability study is to establish, based on testing a minimum of three batches of the drug substance or product, a retest period or shelf life and label storage In the early stages of product development, initial determinations of product stability can be made by testing samples from laboratory batches under appropriate conditions. As development progresses, it may be necessary to make more precise determinations of probable stability by testing samples from batches manufactured with equipment In the early stages of product deve