Blog Introduction

Regulatory requirements for production and control of Pharmaceutical and bio-pharmaceutical products vary from country to country. Also, Good Manufacturing Practice (GMP) requirements are not harmonized across the nations. Though ISO 9000 standards has been there since 1987, pharm/bio-pharm is the only industry where Quality Management System (QMS) was not adopted until the publication of ICH Guidance Q10. This is because this industry is governed by National Regulations having stringent Rules and Acts for manufacture, control and trade of these products. With ICH Q10, QMS has been emphasized by all the regulatory agencies. 

Requirements of ICH Q10 are similar to ISO 9001:2008 and follow ‘product life cycle approach’. However, ISO 9001:2008 remains a Gold Standard for implementation of QMS in any organization.

In this era of international trade, meeting all the national and international regulatory and GMP requirements is a necessity. A major challenge is developing a QM System which satisfies all international regulatory and GMP requirements, requirements of the product, customer requirements.

In QPath documents required for implementation of QMS in GMP setup along with supporting documents are published. The structure and design of documents roots to vaccine manufacturing setup but are applicable to Pharma/Bio-pharma as well. Wherever applicable, references are sighted.

Further Readings:

ISO 9001:2008 Quality management systems — Requirements

ICH Q10 Pharmaceutical Quality System