PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
These are possible approaches to gaining a more systematic, enhanced understanding of the product and process under development. Quality Target Product Profile (QTPP): A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. The … Read more
Foils: Foils are basically acts as primary barrier. Different types of foils are there acts as both base foil and lidding foil. Main role of foil is to protect the drug from Moisture, Light, and Contamination with external environment etc. Examples for different types of foils based on composition.1) PVC foil2) PVC-PVDC foil3) PVC-PE-PVDC foil4) … Read more
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
