Top 5 non-conformities in GMP Audit for pharmaceutical industry

Good Manufacturing Practice (GMP) audit is a mandatory compliant requirement for pharmaceutical industry. It is vital for ensuring pharmaceutical quality, minimising risks, and maintaining consumer trust for this important industry that save lives. As we deliver multiple GMP audits a year, we are summarising our findings to share top five non-conformities observed in GMP audits. Pharmaceutical companies can take reference to our sharing and look to improve their own performance amid all the challenges.

What is GMP non-conformities?

What is a non-conformity, first thing first? Simply put, a failure to meet defined requirements is called non-conformance or non-conformity. Process and product non-conformity are both possible. Often, non-conforming practices result in non-conforming goods. Some examples of these non-conforming practices include improper implementation of management system and deviation from normal operating procedures.

Non-conformities identified during GMP audits serve as a barometer of the present situation relating to the manufacturing processes of pharmaceutical products. Through analysis of non-conformities, we are able to find out areas that need particular attentions and corrective actions, thereby better minimising safety and quality risks on the final products.

Let’s now have a look in detail at the 5 most common non-conformities in GMP audit in pharmaceutical industry.

Absence of documentation

One of the most common non-conformities is the lack of proper documentation. Pharmaceutical manufacturers are required to maintain proper documentation and paperwork, according to the fundamental guidelines of GMP requirements. Planning a manufacturing function's future actions can be facilitated by documentation, which helps to create a comprehensive picture of the function's past and present activities. When auditing manufacturing sites, auditors frequently take their time to go through the paperwork and records of the companies for data and information validation. Keeping incomplete records of quality control testing, equipment maintenance, and production processes will eventually result in non-conformity.

Pharmaceutical companies should build robust documentation systems and periodically assess and improve their documentation procedures to prevent this issue from arising.

Inadequate training programme for internal auditors

Inadequate training can easily lead to mistakes, deviation from approved standards, and breaking GMP regulations. In the case of inadequate training of internal auditors, deficiency of the internal audit program is likely to happen.

In order to solve this problem, companies should put in place extensive training programmes that cover every aspect of GMP compliance. Periodic updates should be provided to employees properly.

Insufficient Change Control Management

The process of managing changes to established procedures, machinery, or facilities is known as change control. Unauthorized or poorly regulated changes can emerge from ineffective change control management, which might cause compliance problems. It is crucial to set up a strong change control system with comprehensive change evaluation, documentation, and approval procedures.

Ineffective supplier management

Poor supplier qualification may result in the usage of raw materials or services of lower quality, which would impact the final pharmaceutical products directly and adversely. It is vital to establish a comprehensive supplier qualification programme that include audits and continuous monitoring to ensure that suppliers fulfil your compulsory quality requirements.

Lack of proper maintenance of equipment

For GMP compliance, keeping equipment in good condition is essential. Equipment that is not properly maintained increases the chance of contamination and lowers the quality of the products. To avoid equipment-related compliance issues, manufacturing equipment must undergo routine calibration, maintenance, and cleaning.

As GMP compliance is a crucial action for pharmaceutical industry, companies should take proactive endeavour by not only addressing the top five non-conformity issues discussed in this article, but also different aspects on GMP adherence. We have been providing GMP audit for the pharmaceutical for two decades with different services to assist you on GMP compliance. Contact us for proposals anytime!