Quality Control of Raw Materials and Active Ingredients

Testing of your raw materials and active ingredients ensures the quality of your products 

Laboratory controls are an integral part of Good Manufacturing Practice (GMP) and the requirements thereof are described in the GMP regulations. Quality controls for raw materials and active ingredients comprise identity, purity and content testing and are carried out following the regulations of the Pharmacopoeia or according to the customer’s own instructions. 

As your contract laboratory for pharmaceutical analysis in Switzerland, we are accredited according to ISO 17025 as well as being GMP and cGMP (FDA) certified. As part of the process, we consider ourselves to be a part of your quality system. You will receive chemical and microbiological quality control, professional consultation and competent service from one source. 

Our analytical services have been arranged to offer the pharmaceutical industry integrated analytical solutions and as a result, to support or to supplement company laboratories by the means of outsourcing. The comprehensive range of analysis services from our laboratories allows us to carry out just about every test in-house and provide service from one source. This includes chemical, spectroscopic, chromatographic, galenic and microbiological tests , that are carried out in specialised laboratory units.

Quality controls in accordance with the Pharmacopoeia

The Pharmacopoeias are the reference work in their respective geographical areas of application for the quality control of drugs and their source materials. The standards published within define the legal and scientific foundations for quality control in the development, manufacturing and marketing of pharmaceutical products. The qualitative and quantitative composition of the substances and materials are described, along with the tests that are to be carried out on the finished and intermediate products as well as on the raw materials. All manufacturers of drugs or substances used for the production of drugs must comply with the quality standards described in the Pharmacopoeia to be allowed to bring their products to the market in the corresponding geographical region. 

UFAG LABORATORIEN routinely carries out testing in accordance with the following pharmacopoeias:

• European Pharmacopoeia (Ph. Eur., EP)
• US Pharmacopoeia (USP/NF)
• Japanese Pharmacopoeia (JP)
• British Pharmacopoeia (BP)
• French Pharmacopoeia (Ph. Fr.)
• German Pharmacopoeia (DAB)
• Swiss Pharmacopoeia (Ph. Helv.)
• Homeopathic Pharmacopoeia (HAB)

The scope of the testing

If a raw material or active ingredient is described in a monograph in the relevant Pharmacopoeia, it is essential that the tests that are described there are carried out so that the minimum legal requirements have been fulfilled. It is often sufficient if identification testing is carried out on the individual packages/containers from one batch and content and purity determination is carried out in a mixed sample. Every manufacturer has the opportunity to carry out further testing if they consider it to be essential for guaranteeing a smooth running production process or a very high quality product. As a result, production relevant galenic parameters such as grain size or tamped density frequently undergo additional testing.

Validation status of approval methods

The analytical methods that are described in the monograph for a substance are considered to be validated. When carrying out the test, the method must however be verified in suitable ways to verify that the laboratory has mastered the method. This is done by, for example, using reference and blind samples. 

The analytical methods described generally in the general section of a Pharmacopoeia should not necessarily to be considered valid for every substance. If such a method is to be used for a substance that is not described with a monograph in the Pharmacopoeia, then product-specific validation will be necessary.

Quality control in accordance with the customer’s requirements

If you have your own monographs for raw materials or active ingredients, because the substances have not been described in the relevant Pharmacopoeia or because you carry out further reaching tests, we would be please to test in accordance with your specifications.
We will transfer your monograph or testing guidelines after the method transfer into our SOP system and carry out the tests correspondingly when ordered.

GMP contract - the Technical Agreement GMP

In accordance with chapter 7 of the GMP guidelines, it is necessary to conclude a contract when subcontracting out production or analysis. In this GMP technical agreement, the responsibilities and accountabilities in analysis and production in accordance with GMP will be clearly defined.

Do you require additional information? 

Please read the unabridged version in our technical article (see the right-hand column) or ask for advice from our customer services.

Our services in detail:

• Consultation on quality controls
• Quality controls in accordance with the Pharmacopoeia
• Quality control in accordance with the customer’s requirements
• Physico-chemical, spectroscopic and chromatographic testing
• Microbiological controls
• Bioanalytical methods
• Method transfer
• Method verification
• Method validation
• Integration of the customer’s specifications and SOP-system
• The creation of SOPs and a testing plan in LIMS
• Documentation and raw data archiving conforms with GMP
• Additional services are according to the directory of services  or upon request