Mahummed Asif The analysis will be carried out in the lab and after analysis if the received material is appropriate (complying with all the specific limits) Material will be released by the QC which means it can be used for the Packing of the Material. For Primary Material: For Secondary & Tertiary Material: Different type of testing … Read more
What is packaging? Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Importance of Packaging To produce a pharmaceutical product with high quality standards and even it is more important to protect that product form the degradation, external contamination and other physical/chemical … Read more
A variation is a change to the dossier of an authorized product. In terms of Marketing Authorizations (MAs) a Variation is: “an amendment to the contents of the documents referred to in Articles 8 to 12 of Directive 2001/83/EC” Once an MA has been granted, the Marketing Authorization Holder (MAH) has a legal obligation to … Read more
WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more
Pharmaceutical manufacturers have an obligation to ensure that their manufacturing equipment is properly designed, installed, tested, operated, and maintained throughout their service lifetimes. During these service lifetimes manufacturing equipment will likely require both preventive and corrective maintenance activities that may involve the replacement of parts within the systems. Parts replacements must be performed under the … Read more
Technology transfer is both integral and critical to drug discovery and development process for new medicinal drug products. A major decision focuses on that point where the idea or process is advanced from a research-oriented program to targeted toward commercialization. Generally, the cost of product development rises dramatically during the pilot scale-up and initial production … Read more
Alternate Vendor development for existing material shall be initiated through the Change control procedure. Supply chain / purchase team on its own or on the recommendation of Technology Transfer team / R&D / Production shall identify the vendor for existing material. Supply Chaim (SCM) / purchase Team shall initiate queries with the prospective vendors for … Read more
Blending in its simplest form is the combining of two or more materials to produce a homogeneous mixture. These materials may be any combination of particulate (solids blending) or particulate and liquid (liquid-solid blending). Normal tumble blending of free-flowing materials provides a gentle mixing action. For materials that tend to lump or for high intensity … Read more
Homogenous mixing of dry & wet powders, de-agglomeration / de-lumping of wet mass and fast dispersion of binding agent. Dust free, high free flowing dosing particles, high uniformity of granule size. AC frequency control for bottom driven Impeller Mixer with 3 or 4 blades with exclusive scrape side design and Chopper positioned to make granules. … Read more
Fluid Bed Dryers (FBD) are primarily used in almost all chemical, pharmaceutical, food, dyestuff and other process industries to dry materials by fluidization with hot and / or dehumidified air, which creates a turbulence in the wet product (not totally liquid) while flowing through it. WORKING PRINCIPLE: The atmospheric air is sucked in the dryer … Read more
