Pharma Digest
Difference Between 21 CFR Part 11 and EU GMP Annex 11
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part III
A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures. Although the presentation may differ from the order described here, it must comply with Good Document Practice (GDP). The following standard operating procedure sections ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part II
A SOP is a document that provides high-level guidelines for a process. There are different types of SOPs in the pharmaceutical industry. To be most effective, standard operating procedures should be succinct, intuitive, easy to navigate, traceable, and regularly approved. To ensure compliance and traceability to a qualified state are ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part I
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs. SOP management refers to the systematic ... Read More
GxP Compliance Checklist | 5 Ps
GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211. List of GxP Compliance ... Read More
How to Create a Validation Master Plan?
Validation master plan (VMP) is a high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of ... Read More
How the ICH Quality Guidelines Fit Into the Drug Development Process
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration ... Read More
GXP Compliance | The Future of Validation
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the ... Read More
Why Change Management is Important during CQV?
Change management is crucial in any Commissioning, Qualification, and Validation (CQV) activity within the pharmaceutical and other regulated industries for several important reasons: Robust change management helps ensure compliance, manage risks, maintain product quality, and facilitate efficient and controlled change implementation. It is an integral part of maintaining the quality, ... Read More
FDA Requirements For OTC Drugs
An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the ... Read More
Commissioning, Qualification, and Validation (CQV) in Pharmaceutical Industry
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the ... Read More