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Pharmaceuticals Solid Dosage Manufacturing Facility Design

Pharmaceuticals Solid Dosage Manufacturing Facility Design

Solid dosage forms, primarily tablets and capsules, represent the largest category of pharmaceutical products by volume. The design of facilities for ...
Pharmaceuticals Cleanroom Features and Construction Materials

Pharmaceuticals Cleanroom Features and Construction Materials

All cleanroom surfaces must be non-porous, non-shedding, easily cleanable, and resistant to the cleaning agents and disinfectants used. Joints and sea ...
GMP Requirements for Pharmaceutical Facility Design

GMP Requirements for Pharmaceutical Facility Design

Pharmaceutical facilities must be designed, constructed, and maintained to ensure that products are consistently manufactured to the required quality ...
PIC/S Classification System for Pharmaceutical Sterile Products

PIC/S Classification System for Pharmaceutical Sterile Products

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organization between pharmaceut ...
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 ...