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…
An HVAC system in pharma is the engineered set of air-handling equipment and controls that maintains the required cleanliness, temperature, humidity, airflow direction, and pressure cascade in manufacturing and support areas—so products are protected from contamination and cross-contamination, and (where…
A compressed air system in pharma is a critical utility used for pneumatic valves/actuators, instrument air, cleanroom equipment, tablet presses, packaging machines, and blow-off Because air can contact product or product-contact surfaces indirectly, it must be designed and controlled to…
Here’s a practical, end-to-end overview of a Purified Water (PW) system in pharma: pre-treatment → generation → storage → distribution—what each stage does, typical equipment, and key GMP controls. 1) Pre-treatment (protect the RO/EDI and stabilize feed quality) Purpose: reduce…
Air Handling Unit (AHU) qualification is a key GMP activity to ensure that HVAC systems consistently provide the required environmental conditions for the manufacturing of pharmaceutical products. AHUs control temperature, relative humidity, air cleanliness, pressure differentials and airflow patterns, all…
A nitrogen system in a pharmaceutical facility provides a clean, dry, inert gas used to protect products, equipment, and processes from oxygen and moisture. “Know your nitrogen system” means understanding the full path—from source to point of use—so you can…
Understanding Warehouse in Pharma A pharmaceutical warehouse is much more than a storage space. It is a GMP-controlled area where medicines, raw materials, packaging components, and intermediates are received, stored, protected, and issued in a way that preserves their quality,…