Why is a quality management system is mandatory in the Pharma Industry

Why is a quality management system is mandatory in the Pharma Industry?


The operations of the pharmaceutical industry are subject to strict regulations as it serves people directly for their health reasons. More than the products of any other sector, the pharma produce needs to be reliable on various parameters. Quality experts emphasise on the adoption of the quality management system (QMS) by the pharma firms in compliance with the ISO 17025  to deliver standard medical products to customers. Implementation of a robust QMS is mandatory for a pharmaceutical company. The QMS must factor in all conformity standards set up by regulatory bodies like the FDA, ensuring the delivery of safe and healthy products to customers.

Essential features of QMS in the pharma sector

In order to be effective, the QMS of a pharmaceutical company should incorporte the following features:

Organizational structures

Before implementing a QMS, a pharma company should work towards getting legally recognized. To make the QMS effective, the organization should have a structure congenial and supportive of its implementation. For standard compliance, the laboratory needs to well-equipped and staffed with skilled technicians. For monitoring the lab’s activities, the company must appoint a Technical manager with a well-defined role and set of responsibilities. The executive should have direct access to the management to keep it informed about the critical activities.

Technical staffing

It is of critical importance for organisations to man their labs with well qualified and skilled technicians, whose activities are monitored by a medico-quality expert. The staff should be well-versed with the handling of different types of equipment, sample testing, issuing test reports based on rigorous analysis.

Effective system of Documentation

Documentation is critical for the successful functioning of a QMS. It is a mechanism to standardise procedures for the manufacturing and testing tasks. It also serves as a basis for monitoring the quality system in the company. Good documentation should comprise a hierarchy of essential quality-related documents, the most important of them being Quality manual, which details out the policy, structures of the laboratory, procedures, and the technical and administrative responsibilities of the staff for the execution of the QMS.

Document Control

It is essential for all pharma companies to exercise rigorous control over their documents, both internal and external. The set of measures encompasses tasks on documents creation, amendments, reviews, approvals, distribution and their archiving. For observing continual improvement latest versions of documents based on compliance standards should be furnished to the technicians and testers and hence, their data should be validated by electronic records and automated data-capture systems.

Regular Audits

An audit is a systematic, independent and documented process undertaken by an organisation to obtain evidence for performance evaluation. The main objective is to asses to what extent the staff has been successful in fulfilling its audit criteria. All companies conduct two types of audits, internal and external. For these audits the quality staff should make all its quality documents readily available.  The management should clearly define for its staff the criteria, scope and objectives of the audits.

Corrective and Preventive Action

The onus lies with the erring organisation to delve into an investigation to determine the root cause of non-compliance or failure. Once the reasons are unravelled, corrective action needs to be undertaken promptly. After the resolution of non-conformity issues, the staff needs to devise measures to ensure a similar problem doesn’t arise in the future.

Complaints and Feedback

Customer complaints and feedback help pharmaceuticals to assess their the laboratory performance and effectiveness of their products. Hence, the QMS should develop a system to document, evaluate and conduct prompt follow-up actions. The staff should follow the standardised procedures to resolve customer complaints promptly.


Pharmaceutical organisations can produce quality products if they are under the reign of an active and effective QMS. Organisations dealing in manufacturing, testing or storage of drugs and other health-related medicines need to keep a constant watch on the quality of their products. Conformity to regulations and standards of international authorities make it mandotory for pharma firms to invest in a good QMS.

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