Pharma Digest
Isolation and Identification of Impurities and Degradants
The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation to prevent these impurities and degradants. ... Read More
Analytical Method Validation
Analytical method validation is a process used to prove through scientific study that the method is suitable for its intended use. Compendial methods have to be verified for suitability under actual conditions of use and for a particular formulation. The validation of analytical procedures is directed to the four most ... Read More
Analytical Method Development Process
Analytical method development in pharmaceutical industry is a risk-based approaches for the assessment of the quality of drug substances and drug products based on product QTPP and CQAs. It’s determine what to measure and when to measure. The goal of method development is to obtain an analytical method fit for ... Read More
How to Increase Solubility of Drug?
The solubility of drug molecule is one of the most challenging aspect in formulation development. It is crucial to ensure the right concentration of a drug gets into the bloodstream so the bioavailability of the drug causes the desired pharmacological response. Therefore, using a variety of techniques to improve solubility ... Read More
Contamination Control Strategy (CCS) for Pharmaceutical Industry
Defining a well-documented cross-contamination strategy involves several key steps. When defining a CCS (contamination control strategy), it is recommended to consider not only cross-contamination but also all other types of contaminants. While the majority of available guidance (e.g ECS, PDA, Annex-1 of EU GMP) primarily focuses on parenteral preparation, it ... Read More
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
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