Setting up a Pharma Unit What latest Quality Management systems should I follow 1

Setting up a Pharma Unit? What latest Quality Management systems should I follow?


If you are embarking on a venture of setting up a pharma unit, it is imperative that you beforehand understand the vital needs and functions of a pharmaceutical quality system. Today, quality consciousness for all products is rife among customers. When it comes to the pharmaceutical industry, expectedly the need to deliver quality assumes paramount importance.

Pharma products directly affect people’s body and health. Hence, in a bid to ensure quality and safety standards, regulatory bodies like the FDA exercise rigorous and continual surveillance over their manufacturing. Additionally, the International Conference on Harmonization provides internationally harmonized guidance to pharmaceutical companies. ICH Q10 demands a quality management system ( QMS) for the Registration of Pharmaceuticals for Human Use and USFDA. If you seek to establish a pharmaceutical manufacturing unit and achieve success, remember you cannot do it without a robust QMS.

Latest QMS you should follow

Your QMS should be based on the guidelines of the latest pharmaceutical quality system which is internationally recognised and accepted. The International Conference on Harmonization (ICH), a joint initiative of Regulators and Research-based bodies spanning Europe, Japan and the US has devised standards and procedures for the pharmaceutical industry for attaining quality excellence in their products and services. Its chief aim is to ensure production based on – Safety, Quality and Efficacy. ICH 10 expounds a QMS model guided by the International Organization for Standardization (ISO) standards. The model encompasses and addresses critical quality concerns like good manufacturing practice (GMP), and complements regulation while emphasising on innovation and continual improvement during the entire length of the production cycle.

At the basic level, your pharma unit’s QMS should accomplish:

a) A proper system of infrastructure outlining the organizational structure, procedures, processes and resources

b) A set of systematic actions for contributing to the eventual delivery of quality based, customer-satisfactory products and services. This system will aid your QMS staff in performing Quality Assurance functions smoothly and efficiently.

Key Functions of a Pharmaceutical QMS

A pharmaceutical company is engaged in the manufacturing and sale of biotechnology and biological products. Your manufacturing processes would require constant and several layered quality checks at each stage and at all levels of the product lifecycle.


a) APIs development and manufacture

b) For investigations manufacturing of medical kits and devices

c) An efficient medical delivery systems

d) Pilot plant activities

f) Development of the essential medical devices for measuring accurate dosing

Analytical – manufacturing-related

a) An effective system of checks for acquisition and control of materials

b) Adequate provision of facilities and equipment

c) Production-related to including packaging and labelling

d) Storage at the stage of product technology transfer

e) Testing and quality assurance mechanism

System for product discontinuation

a) Sample retention and maintenance of documents

b) Continual assessment of products and reporting

Quality Management System in Testing Laboratories

While abiding by the ISO mandates on risk and safety, your laboratory staff would need to align its testing activities in line with them. Keeping the end-user in mind the pharmaceutical companies should possess a well-equipped laboratory manned by qualified, trained and skilled medical professionals. The staff is obliged to offer rigorous testing for all the company products and services before they are packaged for market.


Given the nature of their needs, the products and services of the pharmaceutical sector need to manufactured and provided under stringent regulations. Commonly, legal actions are taken against non-compliant firms. Hence, if you are to set up a pharma unit, keep quality production as your top-most priority. And, it goes without saying the purpose cannot be achieved without the presence of an active, alert and robust quality management system.


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