Quality Control for Products and Approval Tests

Laboratory controls are an integral part of Good Manufacturing Practice (GMP) and the requirements thereof are described in the GMP regulations. Quality controls for the approval of drugs comprise identity, purity and content testing and are carried out according to the manufacturer’s instructions submitted at registration.

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. If we carry out chemical and microbiological approval testing for you, we consider ourselves to be a part of your quality system.

Our offer of service has been oriented so that we can offer you integrated analytical solutions and hence relieve or supplement the laboratories of your company by the means of outsourcing. The comprehensive range of analysis services from our laboratories allows the most common analytical methods to be carried out in-house and thereby provide approval testing from one source. This includes chemical, spectroscopic, chromatographic, galenic and microbiological tests, that are carried out in specialised laboratory units.

Regulatory requirements for product approval

The regulatory requirements for the approval of a completed drug are described clearly in the GMP guidelines. The product must contain the active ingredient in the qualitative and quantitative composition corresponding to the application documentation and must exhibit the level of purity necessary. Testing must be performed using validated methods that are suitable for guaranteeing the quality of the drug. Records of the analytical testing must be documented in a way that is complete and comprehensible according to the GMP guidelines.

Validation status of approval methods

Approval testing according to GMP must be carried out with validated methods. For new products, it is essential to develop suitable analysis methods for release or for stability testing. For this it is necessary to compile, on the one hand, exact information about the product and its galenic formulation; but chemical and technical analysing expertise is also necessary to develop the most suitable analytical methods.

The methods of analysis for a product must be validated before the start of clinical trials at the latest, i.e. before being used in humans. The validation of an analytical method provides evidence that the method selected for the intended analysis purposes is both suitable and applicable. Which procedure parameters are to be determined is dependent on the type of analysis and is described in the ICH guideline Q2(R1) and in the FDA guidelines.

Method transfer 

If you have already developed and validated analysis methods for product approval and we are to carry out the testing for you, then a method transfer is, as a general rule, necessary.

Transfer of the methods from your laboratory to ours is carried out after a mutually agreed method transfer protocol has been defined beforehand. With the tests and arrangements described within the protocol, it will be guaranteed according to GMP that the methods will also be valid when carried out in other laboratories or using other equipment.

To obtain this verification, nowadays, the precision in both laboratories will normally be compared with each other. Often, this is done with 6-level determination which must fulfil the previously defined specifications to the 100 % level. The results will be documented in accordance with GMP guidelines in a method transfer report.

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.

Implementation of quality control for product approval

We will test your finished product samples for implementation of approval testing in accordance with your specifications and the transferred procedural instructions.
In doing this we incorporate your monograph or testing guidelines into our SOP system, after the method transfer, and create a test plan in our LIMS. When instructed, we will the carry out the tests correspondingly.

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 control and approval testing 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