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GxP Compliance

Blockchain GAMP5 10

Blockchain technology can enhance compliance in the pharmaceutical field. What is the connection and how you can apply blockchain to your business?

Regulatory Affairs

Environmental Risk Assessment of Medical Products for Human Use: Comparison between EMA & FDA Requests

The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.

Pharmacovigilance

Is your internal personnel and sales force adequately trained? And your pharmacovigilance staff?

Trained personnel play a vital role in ensuring medicinal safety in the animal health business. To achieve this, companies must focus on two primary.

Medical Cannabis

Production according to GACP and GMP (2/4)

Second edition, on the importance of Quality Control of the cultivation conditions, to guarantee a reliable and consistent end-product.

CSV & Data Integrity

Begin with the End in Mind: Back to the Focus of Quality - About the Application of GAMP5 Ed02 in CSV Projects

The best way to apply the GAMP5 second edition in CSV Projects - Begin with the End in Mind

Annex 1

Contamination Control Strategy: a Guide through the Road for its Preparation

The Contamination Control Strategy plays a vital role in the framework of the revised EU GMP Annex 1, encompassing critical control points and.

Medical Cannabis

Cannabis-derived products for chronic pain treatment for cats and dogs

The use of cannabinoids in veterinary medicine is controversial for ethical and legal reasons. The approval of drugs from the competent authorities...

Clinical Research

ICH GCP E6 R3 draft guideline: main changes and clarifications

The ICH GCP E6 Working Group published the draft of the ICH GCP E6 R3 Guidance on May 19, 2023. Stakeholders can provide comments on the guideline.

Clinical Research

Recommendation on decentralized elements in clinical trials

The EU Commission released a recommendation paper on decentralized elements in clinical trials in late 2022. The document addresses the increasing...

Engineering

The importance of the contamination control strategy (CCS) in relation to Annex 1

The CCS concept permeates the entire Annex 1 document and is a fundamental principle. It indicates examples and topics that need to be addressed.