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Process and Control Today | Flexibility in pharma processes: Today's pharma manufacturing needs

06/05/2021 COPA-DATA UK Ltd
Today, pharmaceutical companies are confronted with more frequent changes in production, but industry needs to ensure it is at the forefront of innovation in a time of a healthcare crisis. Here, Giuseppe Menin,
Industry
Manager at automation software supplier COPA-DATA, explains why modular production is crucial for enabling more flexible pharmaceutical production.
Public awareness regarding the complexity of pharmaceutical production has never been so widespread, with the effort of life science companies working at breakneck speed to develop safe and effective treatments to respond to the COVID-19 pandemic being well-documented.
Pharma facilities are being set up, or even converted, to produce the COVID-19 vaccine in several plants to help increase its availability and the need for flexibility is clear. From producing new drugs in small batch sizes, to reconfiguring machines or equipment in already validated lines, pharma man ....

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Important cGMP Considerations For Implementing Electronic Batch Records

Important cGMP Considerations For Implementing Electronic Batch Records
While human error is never the ultimate root cause, mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. In more serious cases, when the error is initially undetected, the consequence can be a product recall. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. These essential requirements need to be included in the initial design phase of the system. ....

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