Extreme care needs to be taken when outsourcing pharmaceutical contract manufacturing

Starting in about the early 2000’s; there have been rather huge and dramatic strides by the pharmaceutical industry in the area of outsourcing. This was on a scale that was unmatched in the industry’s history. Although globalization was set in motion about a decade or so earlier; it started gathering steam around this time. When so many products and services could be outsourced, it was natural that attention was turned towards outsourcing in the pharmaceutical industry, as well.

However, outsourcing in this particular area has its own set of peculiarities, which was to be taken note of. Since this is an industry in which the products can play within the lives of people; it was expected that pharmaceutical outsourcing had to be approached and treaded very cautiously. At the smallest deviation from the prescribed standards; the FDA and other regulatory agencies come down heavily on the pharmaceutical unit, and quite understandably so.

FDA regulations have to be complied with in toto

The FDA issues 483’s and Warning Letters to pharmaceutical manufacturing units that fail to comply even to the smallest extent with its highly stringent prescribed standards. This being the case, it is natural that these players in the industry have to take all the necessary steps to ensure that the contract laboratory or manufacturer to which it outsources meets all the standards set out by the FDA and other regulatory bodies.

This is absolutely necessary because of the high risk that these laboratories face in outsourcing to contract labs. The risk accrues mainly because of one factor: Drug products and API's that are finished at these contract laboratories are released straightaway into the market without further checks. This is why the FDA and other regulatory agencies attach the highest importance to inspections in the contract laboratories.

Reference to an industry guideline

How do parent laboratories and contract laboratories go about their outsourcing method? They have a handy and reliable guideline to refer to. Considering the high scale and nature of outsourcing; the Active Pharmaceutical Ingredients Committee (APIC), in collaboration with the Council of European Federations for the Chemical Industry (or CEFIC in French) developed a guideline in 2010 for the conduct and best practices to be implemented in the area of supplier management in contract manufacturing.

This guideline serves as a good indicator of the way the industry works today. The initial focus of this guideline was on those who supplied materials to those in the business of API manufacturers. The creators of this guideline have acknowledged the need to expand this study to include Laboratory Contract Lifecycle Management into it as part of the next phase of the research. The aim of this study is to ensure that patients get the confidence that they have access to medicines that are safe and have high quality and efficacy, despite the variance of the cGMP documentation from one country to another or one region to another.

Guidelines on all areas of the manufacturing process

This document, considered among the authoritative guides for best practices for contract manufacturing; sets out systems that have to be implemented during the entire lifecycle of the product for managing contract laboratories. The stages include all the steps from the first to the end:

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