Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use.
Quality assurance is a good practice in the manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet the standard for the proposed use. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability. Quality is a benchmark of perfection for the end-user.
We have a well experienced qualified & competent dedicated technical persons in Various departments.
Quality assurance exists to serve a number of objectives that include the following:
• To offer a guarantee that the person who is administering medicine is confident that every unit will achieve the desired effect.
• To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.
• To ensure the law is complied with to the latter.
• To offer protection of the manufacturing organization.
Quality Control refers to the features and characteristics of a product that bears on its ability to satisfy the needs of the consumer. Features like shape, dimension, composition, strength, workmanship , finish and colour.
Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. • New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation
We have well experience qualified & competent dedicated technical persons in Various departments. Our QC department has all necessary instruments for analysis of API, finished products, packaging and related materials used.
The QC department performs following activities:
• Finished Products analysis
• In-process Checks
• Stability Studies
The QC activities are managed through four sections:
• Wet Analysis Laboratory
• Microbiological Testing Laboratory
• Packaging Material -Testing Laboratory
Drug Regulatory Affairs ( DRA )
Premier has a dedicated team for Drug Regulatory Affairs ( DRA ) which is focused in approval of New Drugs, Subsequent New Drugs, FDC`s, Test Licenses, NOC`s, Import Registrations and Import Licenses from CDSCO HQ. The team co-ordinates with highly qualified and experienced R & D Team of the factory for development and preparation of data to be submitted the DCGI office for approvals. The team also coordinates with different CRO’s to conduct BA / BE studies and CT studies as per requirements of the DCGI’s office. Regular Audits are conducted at the various sites to see the proper functioning of the trails / studies.
Regulatory Approvals / Accreditations
• WHO GMP
• NSF International
• ISO 9001:2015
• ISO 17025:2005
• R&D Certification