Skip directly to content

PFIZER CANADA STATEMENT TO CBC MARKETPLACE REGARDING EMERGEN-C®

30/11/15

Below is the statement we provided CBC Marketplace in regards to their questions concerning the quality of EMERGEN-C®.

 

PFIZER’S QUALITY SYSTEMS

KIRKLAND, QC, November 12, 2015 - As a manufacturer of prescription medicines and natural health products, Pfizer is responsible for ensuring that these products are manufactured, packaged, tested and distributed with respect to the highest industry standards in order to maintain the highest level of quality and integrity.

 

To meet this commitment, Pfizer developed manufacturing processes and analytical methods specifically validated for the production and analysis of EMERGEN-C®. Each lot is analysed prior to release to ensure that the manufacturing was performed according to the approved methodology.

 

Each step of the manufacturing and packaging process has been designed to ensure the quality and the integrity of the product from its manufacture to its expiration.  Regular in-process testing is performed throughout the manufacturing process to control and monitor the quality and the integrity of each lot produced. Our rigorous stability program involves placing EMERGEN-C®  products in environmental chambers and analyzing the product at regular intervals to ensure that label claims and unique characteristics are maintained throughout its shelf life.

 

When it comes to analytical testing of any products, all test methods are required to be validated according to current recognized international standards established by the FDA and Health Canada as well as in accordance with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.   It is important to ensure that each method is accurate, precise and specific to the ingredient being analyzed, with consideration to prevent any alteration of the product during the analysis. For example, the use of low-actinic glassware is required for water-soluble vitamins which are sensitive to light.

 

Without a method validated specifically for EMERGEN-C®, any testing cannot be considered valid as the results obtained may not represent the true value of the ingredient being analysed.  As such, we caution CBC Marketplace from making product quality assumptions based on third-party analyses using general methods.

 

STATEMENT FROM PFIZER CANADA INC.

With respect to your specific query, our manufacturing documentation and analytical results for the lot of EMERGEN-C®  Super Orange (Lot number 1410C006) were reviewed and we can confirm that this batch was manufactured according to the validated manufacturing process and our analytical tests results confirm that all ingredients are meeting the label claims.

 

With respect to your query regarding the “helps to maintain immune function” claim, we confirm that this purpose of use is approved and permitted based on the presence of zinc in the formulation as per the Health Canada Multi-Vitamin Mineral Supplement Monograph and the Zinc Monograph.  Pfizer meets the standards of evidence for the product to support this claim.

 

 

For further information:

Media Inquiries:
Pfizer Canada Inc.
1 866 9PFIZER (973-4937)

Customer Service:
1-855-367-7349 or [email protected]