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Derma Manufacturing Glossary

Plain-English definitions of the terms you will meet when launching a derma brand: COPP, MOQ, GMP, Schedule M and more.

AHU (Air Handling Unit)
Equipment that filters and conditions air supplied to manufacturing areas to control cleanliness, temperature and humidity.
API (Active Pharmaceutical Ingredient)
The ingredient in a medicine that produces the intended therapeutic effect, such as ketoconazole in an antifungal cream.
Batch Manufacturing Record (BMR)
The document that records every step, material and check for a specific production batch.
CoA (Certificate of Analysis)
A document that reports the test results of a batch against its specification.
Contract Manufacturing
Manufacturing of products by one company for another company under an agreement.
COPP (Certificate of Pharmaceutical Product)
A certificate issued by the regulatory authority of the exporting country, often required to register products abroad.
Cream
A semi-solid emulsion of oil and water used for topical application; usually non-greasy and easy to spread.
Drug Licence
A licence issued under the Drugs and Cosmetics Act to manufacture, sell or distribute drugs in India.
F&D (Formulation & Development)
The lab function that develops and optimises product compositions before commercial manufacturing.
Gel
A semi-solid, usually water-based topical preparation that is clear and non-greasy.
GMP (Good Manufacturing Practice)
A system of rules that ensures products are consistently produced and controlled to quality standards.
HPLC (High Performance Liquid Chromatography)
An analytical instrument used to identify and quantify the active ingredients in a product.
Loan Licence
A licence that allows a brand owner to have products manufactured at another licensed manufacturer's facility.
Lotion
A liquid or semi-liquid topical preparation suited to large or hairy skin areas.
MOQ (Minimum Order Quantity)
The smallest quantity a manufacturer will produce for one product in a single order.
Ointment
A greasy, semi-solid topical preparation that forms a protective layer on the skin.
PCD Pharma Franchise
Propaganda-cum-distribution: a business model where a partner markets a pharma company's products in a territory.
Private Label
Products made by a manufacturer and sold under the buyer's brand name.
PWS (Purified Water System)
A water treatment system (for example RO, demineralisation and UV) that produces water of pharmaceutical quality.
Schedule M
The part of India's Drugs Rules that sets out GMP requirements for manufacturing premises and practices.
Stability Testing
Testing a product under defined temperature and humidity conditions to establish its shelf life.
Third-Party Manufacturing
Outsourcing production of your branded products to a licensed manufacturer.
WHO-GMP
Good Manufacturing Practice guidelines published by the World Health Organization; certification is granted by the national regulator.
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