QC - Quality control
For a quality control laboratory (QC lab) the main responsibility is analyzing samples. Based on the results obtained, decisions can be made on the material or product quality and safety. Detailed laws and regulations describe amongst others the risks for prophylaxis’ and therapeutic drugs safety. Progress-PME specialists can support you translating these, often complex, laws and regulations to understandable, explainable operating procedures. This will help your organization to be ‘in control’.
The importance of accurate and reliable testing should not be underestimated. Based on analytical data a product will be released or rejected. After release, the product can be administered to or used by humans or animals. To ensure that the product has the expected efficacy and is safe for intended use, the analytical data should therefore be reliable. This reliability can be achieved and assured by implementing systems and methods based on risk based decisions. Progress-PME offers experienced project managers who can support you with performing these type of activities:
Incoming good inspection
- A QC laboratory is responsible for the inspection and release of incoming goods, like the raw materials needed for the production process. This responsibility is even depicted by law. To assure a constant level of quality and to facilitate the production process, adequate and timely release of the materials is essential.
- Usually, the release specifications for each of the materials and the rigorousness of the inspection, are based on a risk assessment. To be able to execute such a risk assessment it is amongst others necessary to know how and where the materials are used in the production process. From the risk assessment critical attributes can be identified, which then are used to determine each material’s specification.
Analytical development and stability studies
- Analytical development
Analytic method development is a key element of any pharmaceutical drug development program. Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Method development is a continuous process that progresses in parallel with the drug development. The goal and purpose of the method should reflect the phase of drug development. During early drug development, the methods should be suitable to support pre-clinical safety evaluations, pre-formulation studies, and product stability studies. Up to and including clinical trial Phase 1, analytical methods need only be qualified, not validated. Linearity, precision, accuracy, and specificity will suffice at this stage. As drug development progresses, the 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 component of pharmaceutical drug development program. They should include testing of those attributes that are susceptible to change during storage and are likely to inﬂuence quality, safety and/or efﬁcacy of the pharmaceutical drug. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
- Progress-PME can support you during analytical development. The Progress-PME experts can provide scientific advise varying from early stage analytical development through complete validation of the methods in order to have an analysis which is “fit-for-purpose”. In addition, Progress-PME can support you to set up a scientific sound stability program. This includes writing of stability protocols and reports, combination of analyses by bracketing and matrixing to be as efficient as possible through data interpretation of the results.