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New German Regulation on the Manufacture of Drugs and APIs (AMWHV)

 

Quality systems regulating the manufacture of drugs and active pharmaceutical ingredients (APIs) have been successfully established in the European Union. These current Good Manufacturing Practices (cGMPs) guaranty the safety of pharmaceutical raw materials and products and their compliance with the quality requirements defined by international pharmacopoeias (e.g. BP, EP, JP, USP etc.).

Kirsch Pharma appreciates the new AMWHV as the transfer of Directive 2004/27/EC into German law demanding the implementation of the GMP Regulations for APIs in accordance with part II of the European GMP Guideline and ICH Q7A.

The new legislation on GMP rules for API’s in Germany reflects Kirsch Pharma’s quality philosophy regarding manufacture and release of pharmaceutical raw materials for our customers worldwide.

The implementation of the new regulation by Kirsch Pharma demands certain provisions in order to comply with the current German legislation.

1) Distinction between active ingredient and excipient regarding their suitability:

Unless not unequivocally labelled as active ingredient all pharmaceutical raw materials as provided by Kirsch Pharma are considered as pharmaceutical excipients even though supplied with multiple pharmacopoeia designations and not specifically labelled as excipient.

2) Assignment of APIs to the original manufacturer:

Active pharmaceutical ingredients not originally produced by Kirsch Pharma will be supplied with the information about the original manufacturer as already done in the past on our customer’s request.

3) Excipients supplied by Kirsch Pharma and utilized by our customers as active pharmaceutical ingredients.

In order to comply with the current pharmaceutical legislation and to be able to perform additional qualification measures, we have to know the specific requirement and purpose of use of our product. We therefore need your cooperation and ask our cus-tomers to contact us directly if applicable.


4) Non-GMP substances suitable as APIs supplied by Kirsch Pharma and utilized by our customers as active pharmaceutical ingredients:

Our product portfolio also comprises substances that come from non-GMP manufacturing processes but have been qualified according to other quality standards. Due to the fact that actually no exceptional or transitional regulation is in place regarding the use of substances not primarily produced as active pharmaceutical ingredients but which the customer may also decide to use as active ingredients, Kirsch Pharma cannot offer these substances as APIs. We therefore ask our customers not to hesi-tate to contact Kirsch Pharma in order to solve any problem regarding future supply with convenient product qualities.

 

Change Control and GMP Statement

As distributor of active pharmaceutical ingredients and manufacturer of atypical APIs, excipients and raw materials for the nutritional industry and other fine chemical products, we operate in accordance with internationally recognized quality standards and regulations concerning the demands of our product portfolio.

In order to guaranty the optimum quality, Kirsch Pharma has established a quality management system that comprises the international standards ISO 9001:2008, HACCP as well as GMP according to annex II of the European GMP directive (ICH-Q7) or IPEC GMP Guide for Bulk Pharmaceutical Excipients. By the means of numerous audits performed by our international customer ship the high standard of our quality system and the implemented GMP-system has been confirmed. In accordance with the actual legal requirements and our quality philosophy we have optimized our production environment according to current and future cGMP standards especially for excipients.

In order to be in perfect compliance with the specific requirements for both APIs and excipients we have therefore started a GMP-update program in 2007 in order to upgrade our production facilities and optimize workflows sustainably. This has been realized together with a renowned GMP-engineering group in cooperation with the responsible GMP-surveillance-authorities. We want to point out that the unit operations conducted by Kirsch Pharma and the basic equipment will not be changed but that the improvements mainly applies to a better control of material and personal flows and the control of the production environment by installation of clean rooms.

The realization phase has started in autumn/winter 2008 and is now accomplished. Although GMP-certification is not mandatory for producers of excipients and normal APIs we have applied for GMP certification subsequently. The certification process by the local GMP-authority will start in July 2012. This is to demonstrate our new standard to our worldwide customer ship. For details we are willing to submit a site file that documents the improved facilities and procedures or invite you to re-audite our site.

The GMP philosophy is accepted and implemented within the company and the general management has committed itself to provide all required resources for its realization. All employees are committed to this project and take the necessary measures to ensure its successful implementation.