Pharma Blog
Data Integrity in Pharmaceutical Industry
Data integrity refers to the completeness, consistency, and accuracy of data. Where complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) throughout the lifecycle of the product. Data integrity is a requirement of current good manufacturing practice (cGMP) for drug ... Read More
APIC Guidance on Aspects of Cleaning Validation in API Plant
This guidance document was published by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC for cleaning validation in active pharmaceutical ingredient manufacturing plants. Six specific areas are addressed in this Guidance document: Acceptance Criteria Companies must demonstrate during cleaning validation that ... Read More
Cleaning Validation in Pharmaceutical Industry
Cleaning validation is a crucial process in the pharmaceutical industry that involves ensuring that equipment and facilities are free of residue and contaminants that could impact product quality and safety. Over the years, different approaches and techniques have been developed and adopted for cleaning validation, each building on the successes ... Read More
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
Unit of Measurement in Pharmacy Practices
Metric SystemThis is a decimal system of weights and measures originally based on the meter as the unit of length and the kilogram as the unit of mass. SI SystemThe International system of units was adopted by the 11th General Conference of Weights and Measures in 1960. The SI units ... 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
Computer Aided Drug Design (CADD)
Computer Aided Drug Design (CADD) has now become an indispensable tool in the long process of drug discovery and development. It includes finding, developing and analyzing medicines and related biological active compounds by computer methodologies. The reliability of the mathematical methods used to obtain and solve the equations is well ... Read More
An Introduction to Lead and Analogue Synthesis
Once the structure of a lead has been decided it is necessary to design a synthetic pathway to produce that lead. These pathways may be broadly classified as either partial or full synthetic routes. The chemical reactions selected for the proposed synthetic pathway will obviously depend on the structure of ... 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