PQR requirements in India, WHO and PIC/S
How PQR rules differ in revised Schedule M, WHO TRS 986 and PIC/S PE 009, and how to turn review conclusions into tracked CAPA actions.
GMP
Linking APR to CAPA, Change control and Revalidation
Turn each APR finding into a clear decision (no action, CAPA, change control or revalidation) and track every action to closure.
Trend Analysis in an APR with control charts and Cpk
How to trend batch data in an APR: choose the control chart, check stability, calculate Cpk with a worked example and write a clear conclusion.
APR Data Checklist by Source System
A practical APR data checklist by source system: what each system supplies, who owns it, and the check that proves the data are complete.
Annual Product Review (APR / PQR)
An annual product review (APR / PQR) checks a year of quality data for each product. Learn what to include, how to trend it and how to act on the results.
Top 10 Common Audit Findings in Pharmaceutical Manufacturing
Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more
Drug Master File (DMF): FDA Guidelines
A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). A US DMF (Drug Master File) is a document that is submitted to regulatory agencies to provide confidential, detailed information about a drug API, drug product, or excipient. It is used to support the approval … Read more
List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy)
Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the difference between Controlled documents and uncontrolled Documents used in the Pharmaceutical documents system. Types of Document Copies in Pharmaceuticals: Master Documents: The originally approved copy of a document Is marked as a “MASTER COPY” stamp … Read more
Revised Schedule M- GMP (using Infographics)
Schedule M was incorporated by the Drug and cosmetic act of 1940 in 1988. Schedule M is also known for Good manufacturing practices. But earlier there were no rules and regulations that dictated us to know, How is our pharmaceutical building, location, premises, water system, construction area, warehouse, etc. Introduction to M Schedule Schedule M … Read more
How to Prepare Batch Manufacturing Records (BMR)
Batch manufacturing records (BMR) are an essential part of pharmaceutical manufacturing as they document the entire process of production and ensure that all steps have been performed correctly. Here are the preparation steps for BMR as per schedule M in pharmaceuticals: Steps for Batch Manufacturing Records Preparations: 1. Design the BMR format: The BMR should … Read more
Usage of Expired Raw Materials to Manufacture Drug (Q&A)
In Industries, we always face confusion about the “Usage of expired Raw Materials” and “Retesting of expired raw materials” in the formulation of finished drug products. in this article, We will cover some Questions about Expired Raw and API materials in warehousing, as we have tried to explain them in a simple way. What is … Read more
Site Acceptance Test (SAT)
SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a Manufacturer site inspection by the user. site acceptance test in pharmaceuticals is done to verify the functioning, operation, and parameters along with manufacturere repersentative. Site Acceptance Protocol Site acceptance test protocol is prepared by the … Read more
3 Types of Airlocks and its Purpose and applications
The airlocks is a transition space that typically has two doors in series to separate controlled environments such as a cleanroom, lab, operating room, or isolation room from the corridor. What is an airlock? Airlocks are commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. In a pharmaceutical … Read more
Granulation Technique in tablet manufacturing
In today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or process of forming or crystallizing into grains. Granules typically have a size range between 0.2 to 4.0 mm, depending on their subsequent use. Synonym “Agglomeration“: Agglomeration processes or, in a more general term, particle size … Read more
Air Change Per Hour (ACPH) Calculation for CleanRoom
Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO CleanRoom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. if the supply of air by the HVAC system in one houres is equal to … Read more
Deviation, Types of Deviations in Pharmaceuticals
Due to the growing demand for GMP and regulatory requirements in the pharmaceutical industry, there is a high chance of deviations occurring. These deviations must be documented, and the manufacturing organization recognizes the need for a standard operating procedure (SOP) for handling such deviations. However, even with good compliance practices in place, there may still … Read more