Cleaning Validation in Pharmaceutical Industry Cleaning validation in pharma is a documented, scientific approach that demonstrates cleaning procedures consistently remove product residues, cleaning agents and microorganisms to pre-defined acceptable levels. It is a core GMP requirement and a critical element…
Change control ensures that any modification to facilities, processes or documents is assessed before implementation. Typical changes are classified as major, moderate and minor based on potential impact on product quality, patient safety and regulatory compliance. Major changes are those…
Form-Fill-Seal (FFS) in pharma is an automated packaging process where a container is formed, then filled with product, and immediately sealed—all in one continuous, controlled operation. It is widely used for sterile liquids (BFS) and some non-sterile products because it…
Opthalmics in pharma are dosage forms intended for the eye (topical or intraocular) and therefore demand strict control of sterility, comfort, and safety. Because the eye is highly sensitive, even small deviations in pH, tonicity, particles, or microbial contamination can…
Temperature mapping in pharma is a documented study used to demonstrate that storage areas such as warehouses, cold rooms and stability chambers maintain uniform, controlled temperatures under normal operating conditions. It is a critical GMP requirement, as temperature excursions can…
OINTMENT TESTS & CHECKS IN PHARMA Ointments are semi-solid preparations applied to skin, eye, or mucosa. In pharma, each batch undergoes specific quality control tests to ensure safety, efficacy and patient acceptability. 1. Appearance & Identification 2. Assay & Content…
An ointment is a semisolid topical dosage form intended for application to the skin or mucous membranes to deliver drug locally (e.g., anti-inflammatory, antifungal, antibiotic) or sometimes systemically. Ointments are generally greasy, occlusive, and provide strong emollient action, making them…
ACTIVITIES TEST FREQUENCY REFERENCE Instrument Calibration As per SOP Yearly (±30 days) As per SOP Type A Cleaning Visual Inspection Batch to Batch or after 10 batches As per SOP Type B Cleaning Visual Inspection Product to Product UV Verification…
Equipment Qualification (EQ) for tablet manufacturing is the documented evidence that each piece of equipment is correctly designed, installed, operates as intended, and consistently performs within defined limits to produce quality tablets. It forms a core part of GMP compliance…
A Pure Steam Generator (PSG) is a critical GMP utility used in pharma to produce high-purity steam for Sterilization-In-Place (SIP), autoclaves, sterile tank/jacket heating, and clean steam applications where product-contact risk exists. Unlike plant steam, pure steam is generated from…