Help Your Contract Laboratory Help You - Pharmaceutical Technology

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Help Your Contract Laboratory Help You
Providing the right information upfront may ease new requirements to assess solvent levels.

Pharmaceutical Technology

Getting to know the regs

Understanding the regulations and their impact on company-specific products, policies, and procedures is another necessary requirement to ensure a smooth and productive relationship between the contract laboratory and the potential customer. Many companies have product commitments to regulatory authorities. Communicating these obligations upfront via a confidentiality agreement will help alleviate misunderstanding and frustration as the project moves forward.

The material details and scope of work should be documented in a project initiation form. Many contract laboratories have a standardized form for potential customers to complete before they start work. In some cases, the forms can be downloaded directly from the laboratory's website and can help expedite turnaround time.

Using the standardized forms provided by the contract laboratory will help increase efficiency as well. The laboratory is familiar with these forms and can readily locate and interpret the work that is being contracted. There are also employees available at these laboratories to assist clients in completing these forms to ensure completeness and accuracy. This helps open up the communication lines early in the process and establishes a solid foundation for the successful completion of the project.

Preparing for more

As regulations continue to evolve, companies are more likely going to be required to retrospectively review their product portfolio. For example, the European Medicines Agency guideline on specification limits for residues of metal catalysts or metal reagents scheduled to come into effect this September aims to "recommend maximum acceptable concentration limits for the residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in drug products" (3). Achieving compliance to this standard may require companies to seek assistance from contract laboratories because, as with residual solvents, the assessment requires an evaluation of excipients, APIs, and final product.

Being prepared to provide complete documentation regarding a project and understanding the regulatory impact of compliance requirements is critical for establishing and maintaining a productive relationship with a contract laboratory. This groundwork is especially important as industry faces more of these new and comprehensive regulations.

Susan J. Schniepp is a guest writer this month while columnist Jim Miller is on vacation. A member of Pharmaceutical Technology's Editorial Advisory Board, Schniepp is a pharmaceutical consulstant at Schniepp & Associates in Boxborough, MA,


1. USP, General Chapter <467> Residual Solvents (Rockville, MD, 2008).

2. H. Ingersol, "Beyond Theory: How to Implement Changes to USP Chapter <467> Residual Solvents," web seminar presentation hosted by Pharmaceutical Technology and sponsored by Celsis, Apr. 22, 2008, available at

3. EMEA, Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents (London, Feb. 2008).


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