White Paper: Managing Change Control to Comply with FDA and EU Regulations

March 31, 2022

International pharma and biotech companies must contend with dynamic market conditions and changes in regulatory bodies’ requirements and guidances. A new MasterControl white paper shows how change control management, when implemented effectively, can help maintain and improve the performance of a quality system amidst a constantly shifting market and regulatory environment. This process, however, is far from simple.

According to the paper, “As stated above, any pharmaceutical change control system requires the interaction of many people in different technical areas. Change control systems are therefore inevitably complex. An inadequate system can cause internal confusion, noncompliance, or worse, a product recall or a product liability lawsuit. In a large manufacturing organisation, dozens or hundreds of changes can be going on at the same time because the timeline for making changes in the pharmaceutical industry can be extensive.”

To read more, click here and register for your free download.

(Source: MasterControl, March 31st, 2022)

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