Ensuring Quality and Compliance in Pharmaceutical Manufacturing

Quality control within the pharmaceutical and life science industry

The Quality Control (QC) area within the pharmaceutical and life science industry plays a pivotal role in ensuring the quality of the product, also referred to as “SQuIPP” which stands for  Safety, Quality, Identity, Purity and Potency of the drug product. It encompasses a variety of processes, systems and techniques that is used to monitor the product SQuIPP” and to confirm compliance with relevant specifications filed at the legal authorities.

One main area in QC is testing and analysis that is used to gain more information about product SQuIPP” where relevant properties (physical, chemical and microbiological) of the product is investigated. Quality Control includes a wide range of tasks and responsibilities and cover the following key areas that are not limited to:

RAW material control:

QC ensures that raw materials used in the manufacturing process (e.g., APIs, and excipients) are tested to confirm the identity, purity and quality. Only materials that comply with the quality limits outlined in the raw material specification are released and used for production of pharmaceutical drug products.

In-Process Control:

QC helps with performing in-process controls (e.g., pH and concentration measurements) on samples taken at specific time points to monitor critical quality attributes to ensure that the product consistently meets quality standards and regulatory requirements throughout the production process.

Finished Product Testing:

The QC team tests the final product to confirm its compliance with requirements outlined in a drug product specification. The drug product is typically tested and verified against specification limits for e.g. potency, purity and other relevant quality attributes to confirm its safety and efficacy before final release to the market.  

Packaging Control:

The QC team also perform physical and chemical testing on packaging material e.g. ampoules, vials and plastic containers as the material of a package affects the quality, efficacy and stability of the drug product. The testing of packaging material is typically conducted against a packaging specification outlining relevant tests and limits.

Other tasks in QC

Sampling process

QC also performs other tasks that is considered as a pre-requisite for controlling the quality of incoming materials and for maintaining a stable process flow.  One of them is sampling of raw materials for testing and analysis. A step by step procedure for the sampling process (e.g. a SOP) and a sampling plan describing how each raw material is handled during and after sampling should be in place to avoid any impact on the quality of the raw material. To achieve reliable results, it is crucial that the sampling process is performed by trained personnel as incorrect sampling can lead to contamination of the samples and hence non-compliance with specification limits which causes unnecessary delays in the process flow and product release to the market.  

Methods and equipment

The equipment and methods used to conduct testing on incoming materials play a pivotal role in confirming product quality.  In order to achieve consistent and reliable results, it is of utmost importance that analytical methods and equipment are validated and qualified against established quality standards. The latter will not only give reliable results but also contribute to  maintaining a predictable and stable process flow.

Data governance

Data governance is another main task in QC with the aim to ensure that data used to support decisions on product quality is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA Principle). Data should throughout its lifecycle from creation and collection to storage meet established standards (annex 11, 21 CFR part 11) to document product safety and regulatory compliance.

This is an enormous task in QC as large amount of data (electronic and paper based) is generated using different kind of equipment and techniques and hence has to be handled and stored properly for later retrieval. Audit trail review in QC is a critical aspect of data governance with the aim to ensure that every change or action taken on QC data is properly documented, traceable, and justifiable.

Performing an audit trail review can for many seem like a very demanding and time consuming task. It involves approaching the equipment, finding the relevant metadata in the audit trail log, verifying  the completeness of the data (user ID, timestamps, evaluate results, type of actions, reasons for any changes) and identifying any discrepancies that should be investigated. This kind of ad-hoc review is preferable as you are continuously assuring product safety and compliance with regulatory requirements.

Moreover, handling out of specification results (OOS), deviations, change controls and CAPAs is a normal practice in QC and also mandatory for continuous improvements and maintaining the integrity of the quality control process.

Spending time on problem solving enhances operational efficiency

Problem solving in QC  is essential for several key reasons and comes into play when handling out of specification (OOS) results or events that deviate from any written procedure outlined in a SOP. Spending hours or days on performing a structured and comprehensive investigation is a cost effective investment that in the end of the day will reduce waste and improve operational efficiency. Every problem solving should be initiated with a brainstorming with relevant stakeholders to identify key elements that should be investigated. The latter should be followed by a Gemba walk (Go/look/see) where different investigation tools such as A3, 5 Why, or a fishbone diagram can be used to structure and conduct the investigation.

Another helpful and necessary step for not only identifying the root cause but also for setting up the right corrective and preventive actions (CAPAs) is to always include the personnel involved in the event and as fast as possible. The people involved often possess the most knowledge about the processes that are impacted which is crucial for your root cause analysis. This approach will not only prevent the error from re-occurring but also lead to continuous improvements, reduce waste, and optimise workflows to deliver at a faster and effective pace without compromising the quality of the work.