To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Document describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms).
The purpose of stability studies is to obtain an evidence on how the quality of drug substance and drug product varies with time under the influence of a variety factors such as temperature, humidity and light, and enables establishment of recommended storage conditions retest period (for drug substances and Intermediates) and shelf life for (drug products).




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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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