by Anna Brambilla – Scientific Project Manager at LS Academy

Transitioning from academic research to the manufacturing division of a biotech pharmaceutical company is a significant shift for a biologist. This new role is not just about applying one’s expertise in cell cultures and bioassays to the corporate sector but also mastering and adhering to Good Manufacturing Practices (GMPs).
These guidelines are critical for a company to obtain and maintain production authorisation.

A new employee will quickly learn that quality is the cornerstone of GMPs. Next is how to implement, ensure and maintain it.

  • Product-related quality ensures that specifications are met to guarantee patient safety and efficacy.
  • Process-related quality necessitates that no activities are left to chance; instead, these should be meticulously standardised and detailed in Standard Operative Procedures (SOPs) that must be adhered to strictly. The production process must undergo validation by generating Process Performance Qualification (PPQ) batches to ensure consistency and control.
  • Production areas-related quality mandates that spaces and premises are consistently monitored and analysed for microbiological or particle contamination and must be duly qualified and validated. Production sites are stratified and categorised into varying zones (or classes): the more critical the activities conducted, the more stringent the requirements for environmental contamination control.
  • Equipment-related quality is needed for any equipment to be used in the production process or GMP analyses; it must first be qualified, validated, and maintained by a predefined and approved plan. This ensures the equipment’s suitability and reliability for its intended use.
  • Documentation-related quality ensures that any process and activity is thoroughly documented per the ALCOA principles. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. While these principles may seem straightforward, adhering to them in everyday operations is not always routine. Many deviations in processes are often linked to non-compliance with ALCOA standards. Common phrases like “If it is not recorded, it did not happen,” “What is this scribble? It is not allowed as a GMP correction,” or “Who performed this activity? When? Where are the date and initials?” highlight the importance of meticulous record-keeping.
  • Personnel-related quality refers to each operator or technician involved in production who must possess the necessary competence and training. The initial training sessions are comprehensive, covering not only GMP chapters and annexes but also specific Standard Operating Procedures (SOPs) tailored to meet GMP requirements in the context of the company’s unique processes and products. One of the more challenging aspects can be the dressing-up SOP, which is especially crucial in maintaining minimal operator-induced contamination. This is vital for cleanroom personnel engaged in the aseptic filling of intravenously administered products, where minimising contamination risk is imperative.

How should we implement, ensure and maintain the quality of all these aspects?

To establish, uphold, and perpetuate the quality of all these dimensions, it’s not only technical expertise and specialised abilities that are vital. What’s equally crucial is instilling the core principles of Good Manufacturing Practice (GMP) across the entire production team. Every individual is accountable for the quality of the output, irrespective of their position or experience level, and should be entrusted with maximum responsibility for this crucial aspect.

A significant shift happens when an individual outside the Quality Assurance (QA) department embraces a quality-centric mindset in daily tasks. Such a person doesn’t merely follow procedures mechanically but is proactive—identifying weaknesses, flagging inconsistencies, acknowledging mistakes, suggesting improvements, and engaging cooperatively with the QA team to enhance the processes continually.

GMP: a quality-based mindset | Blog LS Academy