In comparison with the Federal Decree-Law n8 of 2019, distribution reporting is being reinforced, with notable expansions of scopes, responsibilities and introduction of strict timelines. A national database for reporting counterfeit has been also introduced in an effort to fight such illegal…
Everyone working within the industry must accept the need for a structured and documented change management process. They must first realise the benefits of having a defined change control process, to be able to effectively manage changes that impact on the medicinal products. This is a mindset …
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…
Meeting Good Manufacturing Practice (GMP) standards is essential for trust and reliability, as non-compliance risks product recalls, reputational damage and harm to health. A skilled local GMP auditor ensures effective guidance for your compliance needs.
Let’s unpack what makes regiona…
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…
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