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
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, firstname.lastname@example.org
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).