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ISO Cleanroom Classification System in Pharmaceuticals

ISO Cleanroom Classification System in Pharmaceuticals

According to ISO 14644-1, a cleanroom is "a room in which the concentration of airborne particles is controlled, and which is constructed and use ...
Cleanroom Classification and Design - Details

Cleanroom Classification and Design - Details

Cleanrooms are specially designed and maintained environments where the concentration of airborne particles is controlled to specified limits. They ar ...
Current Good Manufacturing Practices (cGMP)

Current Good Manufacturing Practices (cGMP)

Current Good Manufacturing Practices (cGMP) are regulations enforced by the US Food and Drug Administration (FDA) that provide systems to ensure prope ...
Cleanrooms and GMP Design of Pharmaceutical Facilities

Cleanrooms and GMP Design of Pharmaceutical Facilities

Cleanrooms provide controlled environments where airborne particulate contamination is limited to levels appropriate for contamination-sensitive activ ...
SOP for Good Documentation Practice

SOP for Good Documentation Practice

1. Purpose: To define the common practice to be followed for data entry in all GMP / GLP records. 2. Scope: This procedure is applicable to all G ...
Purified Water Test Procedure in Pharmaceuticals

Purified Water Test Procedure in Pharmaceuticals

01. METHOD OF ANALYSIS i) Appearance Clear, odorless and colorless liquid. ii) pH Transfer 100ml water to a suitable container; add 0.3ml of satur ...
Pharmaceutical Document Control - Short Note

Pharmaceutical Document Control - Short Note

Pharmaceuticals Document Control Workflow 1 DOCUMENT CONTROL SOPs/STPs, BMR/BPR, Specifications, Change History Management. Foundation of GMP compli ...
ALCOA & ALCOA+ Interview Questions & Answers

ALCOA & ALCOA+ Interview Questions & Answers

Basic Data Integrity Q1. What is Data Integrity? Data Integrity means data is complete, consistent, accurate, and trustworthy throughout its lifecyc ...
Data Integrity (ALCOA & ALCOA+)

Data Integrity (ALCOA & ALCOA+)

Data Integrity (ALCOA & ALCOA+) Data Integrity means: Data must be trustworthy, reliable, and accurate throughout its entire lifecycle
Introduction to Pharmaceutics - Study Notes

Introduction to Pharmaceutics - Study Notes

Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or pure drug into a medication that can ...