Pharma Blog
User Requirement Specification in Pharmaceutical Industry
User Requirement Specifications (URS) known as a document, which describe the basic requirement of any Equipment, Instrument, System or Facility in terms of Material of constraints, Model, Capacity, Process, Control System and other cGMP requirements. It is a first document to define the procedure for the procurement of any equipment ... Read More
Vendor Qualification Under FDA and ICH Regulations
FDA, Guidelines, ICH
All contract service organizations and vendors who supply the cGMP facility with critical supplies, reagents, and equipment must be qualified. This helps to ensure all products have been manufactured in a way that prevents the introduction of adventitious agents or toxic impurities and ensures final product safety, effectiveness, and consistency. ... Read More
Structure Activity Relationship in Medicinal Chemistry
Structure-Activity Relationship (SAR) is an approach to find the relationships between a chemical structure of a molecule and its biological activity. SARs are usually determined by making minor changes to the structure of a lead to produce analogues and assessing the effect these structural changes have on biological activity. This ... Read More
Annual Product Review in Pharmaceutical Industry
An annual product review (APR) should be conducted for every commercial product in pharmaceutical industry. The objective of this review is to: APR Relationship to the Quality System SOP for Annual Product Review (APR) Table of Contents Scope and Objectives 1. Applied separately to each product, or product groups, annually. ... Read More
Batch Production Record in Pharmaceutical Industry
Batch production record an important tool in Pharma industry. Always I do believe that, every GMP document in the Pharma industry should be written and reviewed by subject matter experts (SMEs). The insights of the document author and reviewer help in making the document written in logical sense with clear ... Read More
Quality Agreement Guidelines and Template
One of the biggest issues facing the pharmaceutical industry and patients today is quality, integrity and security of the pharmaceutical supply chain, preventing contamination (adulteration) and eliminating counterfeits. A suitable Supplier Qualification Program has hence to be implemented by each user of purchased APIs (or intermediates). A major element of ... Read More
Data Integrity in Analytical Laboratories
Data integrity in the analytical laboratories is an area of increasing focus for regulatory authorities such as FDA, EU, TGA etc. Data Integrity The data which is attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). During regulatory inspection/audit analytical laboratories have to provide information about the ... Read More
Objective of Data Management and Integrity in Pharmaceutical Industry
There are 20 main objective of data management and data integrity in pharmaceutical industry. Let’s check it out – 1. Ensure the accuracy and completeness of data. 2. Maintain data confidentiality and security. 3. Facilitate compliance with regulatory requirements. 4. Ensure consistency of data across different systems and platforms. 5. ... Read More
Introduction to Drug Discovery
Drug discovery is part luck and part structured investigation. At the beginning of the 19th century it was largely carried out by individuals but it now requires teamwork, the members of the team being specialists in various fields, such as medicine, biochemistry, chemistry, computerized molecular modeling, pharmaceutics, pharmacology, microbiology, toxicology, ... Read More
Types of Change Control in Pharmaceutical Industry
In pharma industry, any proposal for change requires evaluation of the change against the marketing authorization (MA) for the product, Good Manufacturing Practice (GMP) guidelines, and patient safety. Most importantly, consideration must be given to the impact of the change on the patient safety. This is the primary concern when ... Read More
Introduction to Drug Action
The action of a drug is believed to be due to the interaction of that drug with endogenous and exogenous substrate molecules found in the body. When one or more active drug molecules bind to the target endogenous and exogenous molecules, they cause a change or inhibit the biological activity ... Read More