Pharma Blog
Asthma Management Guidelines
Asthma is one of the most common chronic disease. In which the reversible airways obstruction and bronchospasm occur and may produce extra mucus. This can make breathing problem and trigger coughing. This is a globally significant non-communicable disease with major public health consequences for both children and adults, including high ... Read More
Drug Master File (DMF) in Pharmaceutical Industry
Drug Master File (DMF) is a package of confidential, proprietary assets, specifying the formula, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Types of DMFs Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel ... Read More
Corrective Action and Preventive Action (CAPA)
CAPA is a fundamental quality management tool for pharmaceutical industry. Implementing an effective corrective or preventive action capable of satisfying regulatory authorities also. Corrective Action The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation. Preventive Action The action was taken to eliminate the ... Read More
Deviation in Pharmaceutical Industry
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. In this article we briefly discuss on types of deviation and management of deviation. Deviation Terminology When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works ... Read More
Excipients in Pharmaceutical Applications
Pharmaceutical excipients are used in virtually all drug products and are essential for drug product manufacturing and performance. Thus, the successful manufacture of a robust product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. The intended end use of the excipient should be ... Read More
Three Systems of Measurement Used in Pharmacy
There are three common measurement systems in pharmacy – the metric system, the apothecary system and the avoirdupois system. The metric system includes units of weight, volume, and linear measure; the apothecary system includes units of weight and volume; and the avoirdupois system includes only units of weight. The Metric ... Read More
Literature Review in Pharmaceutical Product Development
The literature review is an important part of pharmaceutical product development demonstrating literature based knowledge and understanding of the target drug product. The objective of this study is to find out the development and manufacturing feasibility of the product. A list of information to be collected during literature review are ... Read More
Pharmaceutical Raw Material Specification and Template
A raw material specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The ... Read More
Pharmaceutical Finished Product Specification and Template
As per ICH Guideline,A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. ... Read More
Bracketing and Worst Case Rating in Cleaning Validation
The cleaning processes of multiple product use equipment in the facilities are subject to requirements for cleaning validation. The validation effort could be huge. In order to minimize the amount of validation required, a worst case approach for the validation can be used. Bracketing ProcedureThe first thing to do is ... Read More
Cleaning Validation Acceptance Criteria Calculation
The cleaning validation acceptance criteria preferably should be based on the Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) calculations whenever this data is available. The APIC Guidance refers primarily to ADE in the examples of calculations included in this chapter, in line with the ISPE recommended calculations. Acceptance ... Read More