Sterile Drug Substance Manufacturers 7/94 FDA Determine the firm& 39;s criteria for selection of the filter and the frequency of changing filters. of formaldehyde residues on equipment. SIP systems for the bulk drug substance industry require
What& 39;s an Active Pharmaceutical Ingredient API ? The Active Pharmaceutical Ingredient API is the part of any drug that produces the intended effects. Some drugs such as combination therapies have multiple active ingredients to treat different symptoms or act in different ways.
EQUIPMENT SELECTIONPURCHASE SPECIFICATIONMAINTENANCE LIFE STAGES OF EQUIPMENT Equipment management in the pharmaceutical industry has a life cycle and the GMP requirement cover the life cycle of equipment. It starts with decision to purchase equipment and ends with scrapping or elimination of equipment from operation. Decision to purchase equipment is primarily need based.
Presentation - Manufacturing process of biologics o A description of the filling procedure for the drug substance process controls including in- process tests and operational parameters and acceptance criteria should be provided. o The container closure system s used for storage of the drug substance and storage and shipping conditions for the drug substance should be described.
PLI scheme guidelines evoke mix reviews from industry It is well known that bulk drugs/APIs are the basics for the growth of the pharma industry. The government has kept in mind the future growth of the pharma sector while announcing the guidelines. The government intends to ensure that there is an uninterrupted supply of quality drugs and their focus is on research also.
Pharmaceutical industry and unit process Excipients are substances other than the active drug substance or finished dosage form that have been appropriately evaluated for safety and are included in drug delivery systems: USP General Information Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients Dr. ibtihal O. Alkarim 38 39.
Guidance for Industry Q7A Good Manufacturing Practice Active Pharmaceutical Ingredient API or Drug Substance : Any substance or mixture of substances intended to be used in the manufacture of a drug medicinal product and that when used in the
GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE The acceptance criteria for equipment cleaning should be based on visually clean in dry conditions and an analytical limit. Unlike in pharmaceutical production where residues on the surface of equipment may be 100 % carried over to the next product in API production the carry-over risk is much lower for