Maintaining quality and compliance in pharmaceuticals and biotechnology is essential. Good Manufacturing Practice (GMP) certification ensures products meet strict regulatory standards. It safeguards patient safety and protects company credibility. Without accreditation, companies risk failed aud…
Ensuring compliance with Good Manufacturing Practices (GMP) is a matter of maintaining product quality, protecting patients and safeguarding the integrity of your operations. With stringent audits conducted by regulatory bodies like the FDA and EMA, failing to prepare can lead to costly repercus…
Obtaining and maintaining GMP Certification is a prerequisite if your goal is to operate within the pharmaceutical or biotechnology industries. It is one of the steps required to ensure that the company’s products are safe, compliance is obtained, and relevancy in the international market is a…
To ensure quality, safety and regulatory compliance, pharmaceutical and biotech companies need to adhere to GMP standards. Structured procedures are maintained with the help of a GMP compliance audit checklist. It guarantees that no important requirement is missed, maintaining operations’ …
The purpose of computer system validation (CSV) is to guarantee confidence in the data captured, processed, reported or stored on computerised systems. A validated system ensures accurate results and reduces any risks to data integrity.
The extent of validation activities should be defined bas…
Compliance in pharmaceuticals and biotech is non-negotiable. A GMP compliance audit checklist is a tool for regulatory approval and assures you that every process, product and protocol meets the highest safety and quality standards. Regulatory agencies like the FDA and EMA require strict complia…
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