Contribution of CAPA management in Pharmaceutical production quality.

Pharmaceutical industry is one of the industry which needs to satisfy various quality and regulatory authorities like FDA, USFDA, MHRA, TGA and many more for sells and distribution of its products in different parts of the world. Pharma products are directly connected with the wellbeing of human health so the processes involved in Pharma manufacturing should maintain quality in every single step. But majorly the industry players failed to do so. The increasing percentage of warning letters issued by FDA when insufficient CAPA management programs in place.

More comprehensive approach of CAPA

Not having adequate CAPA management is considered a serious compliance weakness. CAPA is the abbreviation of Corrective Actions and Preventive Actions. CAPA investigations are usually initiated by a customer complaint, a regulatory or internal audit, a manufacturing inconsistency or a laboratory investigation. Most companies initiate their CAPA processes after a complaint or product failure has been discovered.

Generally, this is not a good sign for any pharmaceutical business, as it signals a lack of awareness as to the causes of identified problems. While CAPA involves more than just addressing issues that arise in production, at times it seems that problem-solving is the main focus. CAPA experts describe investigations as following a multi-step process – identify the problem, evaluate its magnitude, investigate to assign responsibility and analyze the root cause of the problem.

CAPA management further involves analyzing the root cause analysis and upgrade the processes with proper training to stakeholders to prevent the same problem in future. CAPA methodology is meant to manifest product and process improvements. Effective CAPA management needs consistent process requirements and written procedures.

Inconsistencies across laboratories or facilities leads companies to have recurring problems at multiple operation sites simultaneously, according to Pharma Manufacturing. Smaller pharmaceutical firms are sometimes better able to instate successful CAPA systems and utilize a systematic approach to dealing with problems or complaints because single-site operations generally have more team collaboration and less problems caused by long-distance information management. CAPA requires that consistent requirements and written procedures be in place, and when this is the case, a pharmaceutical company operates more efficiently – especially when aided with powerful technology solutions.