For a Quality Control laboratory (QC lab), the main responsibility is to analyze samples. Based on the results obtained, decisions can be made about material or product quality and safety. Detailed legislation and regulations describe, amongst other risks, the risks for prophylaxis and the safety of therapeutic drugs. Progress specialists can support you in translating these complex laws and regulations into understandable, explainable working methods and standard operating procedures. This helps your organization to be ‘in control.’

The importance of accurate and reliable Quality Control testing cannot be underestimated. A product is released or rejected based on analytical data. After release, the product can be administered or used by humans or animals. Therefore, to ensure that the product has the expected efficacy and is safe for its intended use, the analytical data must be dependable. This reliability can be achieved and guaranteed by implementing systems and methods based on risk-based decisions. Progress offers experienced project managers who can support you in conducting this type of work.

Incoming good inspection

A Quality Control (QC) laboratory is responsible for the inspection and release of incoming goods, such as the raw materials required for the production process. This responsibility is even laid down in law and in guidelines, for example from the United States Food and Drug Administration (FDA) in the guide to inspections of Pharmaceutical Quality Control Labs. To ensure a constant level of quality and to facilitate the production process, adequate and timely release of the materials is essential.

Typically, the release specifications for each of the materials and the stringency of the inspection are based on a risk assessment. To execute such a risk assessment, it is necessary, among other things, to know how and where the materials are used in the production process. From the risk assessment, critical characteristics can be identified, which are then used to determine the specification of each material.

Analytical development and stability studies

Analytical development

The development of analytical methods is a key element of any pharmaceutical drug development program and this is one of our areas of expertise (see Analytical Development). Reliable and reproducible analytical methods are essential for both the pharmaceutical development process and drug product evaluation to meet standards of potency, purity, and stability. Method development is a continuous process that runs parallel to drug development. The purpose of the method should reflect the phase of drug development. During early drug development, methods must be appropriate to support preclinical safety evaluations, preformulation studies, and product stability studies. Up to and including Clinical Trial Phase 1, analytical methods only need to be qualified and not validated. Linearity, precision, accuracy, and specificity are sufficient at this stage. As drug development progresses, analytical methods are refined and expanded based on increased drug product knowledge, and method validation must be completed as the drug progresses through Clinical trial Phase 2 and Phase 3 and commercialization.

Stability studies

Stability studies are an essential part of the pharmaceutical drug development program. They should include testing for those characteristics that may change during storage and are likely to affect the quality, safety and/or efficacy of the pharmaceutical drug. The tests should include, where appropriate, physical, chemical, biological, and microbiological characteristics. Data from these studies allow recommended storage conditions, retest intervals and shelf life to be determined. ICH describes the stability data package for a new drug substance or drug product sufficient for an application for registration within the ICH regions: ICH Q1A (R2) Stability testing of new drug substances and drug products – Scientific guideline | European Medicines Agency (europa.eu)

Progress can support you during Analytical Development and in determining the release specifications for specific materials. The Progress experts can provide scientific advice ranging from early-stage analytical development to full validation of the methods to achieve an analysis that is “fit-for-purpose” for your Quality Control laboratory. Progress can also support you in setting up a scientifically sound stability program. This includes writing stability protocols and reports, combining analyzes through bracketing and matrixing to be as efficient as possible through data interpretation of the results.