29 05, 2024

How would you review a PQR as a virtual QP

By |2024-05-29T16:06:43+01:00May 29th, 2024|Featured|

Reviewing a Process Qualification Report (PQR) as a virtual Qualified Person (QP) requires a systematic approach to ensure thoroughness, accuracy, and compliance. Here is a streamlined and effective way to conduct the review: Preparation 1.1 Understand the Context Scope and Objective: Familiarize yourself with the purpose and scope of the PQR, including the specific process

21 05, 2024

Reviewing a PQR (Product Quality Review) as a QP

By |2024-05-31T13:17:58+01:00May 21st, 2024|Featured|

One of the important aspects of an effective Pharmaceutical Quality System is the Annual Product Review (APR) or Product Quality Review (PQR). As documented in Volume IV, Chapter 1 of the EU GMP Guide, these reviews are required for all authorised medicinal products, including export only products and they should be conducted with the objective

30 04, 2024

5 Points to Consider when Preparing for a Pharma Audit

By |2024-06-07T16:20:15+01:00April 30th, 2024|Featured|

Auditing can be one of the more challenging aspects of managing relationships with contract manufacturing organisations/contract laboratories (CMO/CLO), but as with many processes, thorough preparation can be the key to success. Points to consider when preparing for an audit include deciding whether the audit will be remote or onsite, scheduling of the audit date(s), creation

27 03, 2024

What is a Responsible Person and why do you need it?

By |2024-05-31T13:12:04+01:00March 27th, 2024|Featured|

In the pharmaceutical industry, a Responsible Person (RP) plays a critical role in ensuring compliance with Good Distribution Practice (GDP) regulations. The RP is essential for maintaining the quality and integrity of medicinal products during their distribution process, from the point of manufacture to the end user. This role is particularly crucial for companies involved

20 03, 2024

The differences between an RP and an RPi (import)

By |2024-05-31T13:22:36+01:00March 20th, 2024|Featured|

The Responsible Person (RP) is personally responsible for the implementation and maintenance of a GDP Quality System suitable for the company. The RP is responsible for the quality system and with that also additional responsibilities are defined in the EU GDP guidance or MHRA GDP Guideline. A Responsible Person import (RPi) holds a legal responsibility

29 02, 2024

Best practice for Pharmaceutical GMP Vendor Management

By |2024-05-31T13:23:36+01:00February 29th, 2024|Featured|

For Pharmaceutical companies, vendor management under Good Manufacturing Practice (GMP) guidelines is critical to ensuring the safety, efficacy, and quality of products. Here are five steps to ensure success in pharmaceutical GMP vendor management:   Vendor Selection and Qualification Due Diligence: Conduct thorough due diligence on potential vendors, evaluating their compliance history, financial stability, and

27 02, 2024

Vendor Requalification

By |2024-05-31T13:13:29+01:00February 27th, 2024|Featured|

In any compliant quality system the initial qualification of a vendor represents only the initial step in the relationship. Once initial audits are completed, Quality Agreements and Commercial contracts signed and your vendor moves into routine operation the countdown to their requalification should begin. Requalification audits represent an important element of the Quality System and

21 02, 2024

What is the CAPA process in Pharma Industry? 8 Steps

By |2024-06-11T16:17:55+01:00February 21st, 2024|Featured|

In the pharmaceutical industry, CAPA stands for Corrective and Preventive Action. CAPA is a quality management system approach used to identify, investigate, and address deviations, discrepancies, or non-conformances in processes, products, or systems. Effective CAPA processes are essential for maintaining product quality, ensuring compliance with regulatory requirements, and continuously improving operations in pharmaceutical manufacturing. Here's

31 01, 2024

Pros and cons of Incoterms in the Pharma Industry

By |2024-05-31T13:15:13+01:00January 31st, 2024|Featured|

Incoterms (International Commercial Terms), are a set of standardised terms used in international trade to define the responsibilities and obligations of buyers and sellers in the sale of goods. These terms are published by the International Chamber of Commerce (ICC) and are widely used in international contracts. Using Incoterms in the pharmaceutical industry has both

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