GMP Questions and Answers from the Canadian Authority

GMP News No. 752

GMP News
29 June 2006

GMP Questions and Answers from the Canadian Authority

Like the American Food & Drug Administration (FDA) the Canadian Authority Health Canada also implemented a Questions & Answers area on their website. According to the authority, this Q&A area was updated in May and will also be revised regularly in the future.

The interesting Q&A catalogue which can also be downloaded as PDF, so far comprises the areas premises, equipment, personnel, cleaning, sanitation, raw material testing, manufacturing control, quality control, packing materials testing, finished product testing, records, samples, stability and sterile products.

One of the more recent questions, for instance, deals with raw materials testing:
What documentation does a laboratory have to have in place to be considered qualified to run a test method for raw materials (drug substances and excipients) in order to satisfy Health Canada Regulations?

The authority's answer refers to the proposed USP <1226>, and recommends that "documentation should include a summary of the analytical data, an assessment of the results and comparison to the acceptance criteria, and a conclusion as to the acceptability of the data as they relate to the ability of the laboratory analysts to successfully perform the compendial procedure in the particular laboratory."

Another interesting question refers to sanitation and frequency:
In terms of cleaning, what would be the frequency and type of cleaning for equipment and premises for successive manufacturing of batches of the same product? And for different strengths of the same product?

According to the authority, "interpretation 3.5 under C.02.007 specifies that "a cleaning procedure requiring complete product removal may not be necessary between batches of the same drug". The frequency and type of cleaning for equipment and premises must address the length of time between consecutive lots with the ultimate goal that a particular lot won't be contaminated by the previous lot or the environment. It must also ensure that residual quantities of the previous lot won't impact on the quality of the following lot. Thus, a partial cleaning would be required between two lots of the same product, especially for forms such as liquids or suspensions, in order to prevent a few units at the beginning of a new lot from being filled with residual quantifies from the previous lot that may be located in packaging equipment such as hoses or pistons. It would be required to establish a procedure for the adequate removal of residual quantities from the previous lot and to validate a maximum period of time between two successive productions in order to avoid problems such as microbial contamination or residue drying for certain forms such as creams or ointments."

Further interesting questions as well as the Canadian authority's answers are available at:


Compliance in analytical labs is the focus of the Education Course FDA Compliance in Analytical Laboratories from 4-6 October in Prague, Czech Republic – organised by Concept Heidelberg on behalf of the European Compliance Academy (ECA).
Prepared by:
Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)


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