Documentation

Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records

 

Best Value of Performance Qualification (PQ) 22.

by

Performance Qualification (PQ) is part of the validation master plan in pharmaceutical organizations. This is the method to check the effectiveness, quality, efficiency, and overall performance of the equipment. In a pharma plant, it is necessary that before starting the actual production on the machine it must be qualified through performance qualification protocol and reports … Read more

Best Value of Operational Qualification (OQ) (22)

by

OQ is the Operational qualification that will perform after the successful completion of Installation Qualification. OQ is the major key step of the Validation Master plan. Through OQ protocol we ensure the actual operation of the equipment/machine. OQ protocol is generally provided by OEM also some organization made their in-house protocols and reports on basis … Read more

FAT Best Value of Factory Acceptance Test 2023

by

The FACTORY ACCEPTANCE TEST (FAT) document is the major document and part of the master validation plan in every pharmaceutical organization. It’s a process that is performed at the OEM factory/Site, a pre-check before the delivery of the machine to the pharma organization site. Below details of are factory acceptance test examples.   OBJECTIVE & … Read more

Installation Qualification IQ best value in Pharmaceuticals 24

by

Installation Qualification (IQ) document is a very important document in the VMP (Validation Master Plan) of every pharmaceutical organization. Installation qualification is a documentation process, that will ensure an equipment/machine or instrument has been delivered, installed, and configured at your site in accordance with manufacturer standards and approved with the installation checklist as guided by … Read more

Value of Design Qualification (DQ) In Pharmaceuticals 2024

by

Design Qualification (DQ) is a widely used document in every pharma industry. The DQ is a key input to the commissioning and qualifications as per VMP. After OEM understood the user requirement specification (URS), his team generate the design qualification (DQ) document & submit this to the pharma organization. This also leads to verification that … Read more

URS User Requirement Specification in Pharma 2023

by

URS is the most important document of every pharmaceutical industry which include all information about the particular system or equipment/Machine. URS is the 1st pillar of the VMP Validation Master Plan. URS has all information like Capacity, technology requirements, technical requirements, operational requirements, all types of specifications, etc. In the pharmaceutical formulation plant, the prime … Read more

SOP for Plant Preventive Maintenance EN-01

by

The objective of this Standard Operating Procedure for Plant Preventive Maintenance is to establish a systematic approach to preventive maintenance for pharmaceutical manufacturing plants. Preventive maintenance aims to ensure the consistent operation, reliability, and regulatory compliance of critical equipment and systems. SOP for Plant Preventive Maintenance TITLE: PLANT PREVENTIVE MAINTENANCE 1.0             OBJECTIVE:          … Read more

Pharmaceutical Industries and their value

by

Pharmaceutical Industry and its product categorization Pharma Industries may be categorized into three parts: Pharma Research and development (R&D) facilities. Active Pharma Ingredient Industries (API). Pharma Formulation Industries. Pharmaceutical Industries & Formulation Facilities General Industrial categorization: Pharma Industries and Formulation Plant structure: To run the pharma facility following are the major departments: Quality Assurance Department … Read more