Pharmaceutical industries are involved in the manufacturing of medicinal products which are finally utilized by the patients so a great level of care & compliance is required at each level of manufacturing. What Is a Batch Manufacturing Record (BMR)? 1. A batch manufacturing record or BMR is a document that contains instructions on who…
A Waring Letter (#659142) issued to a US based compounding facility for several serious cGMP violations, including: Several other violations were listed for non-HEPA filtered air, lack of validation of aseptic processes, inadequate cleaning and disinfection, issues with facility design, inadequate environmental monitoring, lack of final product testing and an inadequate stability program. …
RABS (Restricted Access Barrier System) and isolators are both important containment systems used in pharmaceutical manufacturing to protect products from contamination and ensure operator safety. Let’s take a closer look at their specifications, applications, and qualification tests. Specifications – RABS: RABS is a semi-closed system that creates a physical barrier between the operator and…
Pharmaceutical packaging covers a range of types, including blister packs, bottles, and ampoules. Each packaging type serves a distinct purpose in ensuring the safety and efficacy of pharmaceutical products during storage, transportation, and use. The right packaging choice can protect against contamination, maintain product integrity, and provide necessary information for patients and healthcare professionals. …
1. Random Sampling This method involves selecting samples randomly from a batch or lot. It is widely used for various pharmaceutical products. – Guidelines: ISO 2859-1:1999 (Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection). 2. Stratified Sampling In this method, the batch…
When you’re discussing dissolution, it is usually about solid oral dosage forms. Dissolution units can actually be used for any product which releases a drug over time such as medical devices, injectables, and semisolids. The USP has a chapter dedicated to testing semisolids which is USP General Chapter <1724> Semisolid Drug Products – Performance Tests. …
The purchasing process is pivotal. It should be handled by individuals who have an in-depth understanding of both the products and the suppliers. Here are a 5 tips to keep your materials under control: Upon receipt of consignments, diligent checks are mandatory, including: – The package integrity to ascertain there is no damage…
A prominent manufacturer of over-the-counter drug products, was recently issued a detailed FDA warning letter (#663478) for a number of cGMP violations, including: Insufficient Verification of Component Identity The company failed to conduct necessary tests to confirm the identity of each component used in drug products, including high-risk components like glycerin and propylene glycol, which…
