QUALITY MANAGEMENT SYSTEM
Quality is the main element of a pharmaceutical company. Quality is continuous challenge, it cannot be put in final product only it should be built in the product during each stage of manufacturing.
The quality policy of Advent Pharma Limited is to prevent, mitigate and cure the animal illness with quality pharmaceutical products at an affordable price and it is mandated and supported by well-equipped Quality Control (QC) laboratory , which ensures that Advent’s products are pure, safe and effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to regulatory guidelines.
The company aims to improve the processes, products and services continually to deliver with highest professional standards, thereby providing a competitive advantage to the customers and end-users.
The company is pledged bound to ensure maximum customer satisfaction and quality improvement at all times with internationally defined good practices, collectively known as GxP. This includes Good Regulatory Practice (GRP), Good Laboratory Practice (GLP), Good Sales & Marketing Practice (GSMP) and Good Distribution Practice (GDP).
Quality Control department of Advent Pharma Limited has all necessary instruments for analysis of API, finished products, packaging and related materials that are used.
The QC department performs following activities:
- Raw Material / Packaging Material Analysis
- Finished Products Analysis
- In-Process Checks
- Stability Studies
The QC activities are managed through following sections:
- Chemical Testing Laboratory
- Instrumental Analysis Laboratory
- Microbiological Testing Laboratory
- Packaging Material Testing Laboratory
Quality assurance (QA) team of Advent Pharma Limited is responsible for overall control of the documentation system, all activities relating to compliance with the defined procedures, and all regulatory requirements.
- Preparation of validation plans for facility / equipment / process including cleaning.
- Approval of protocols for validation of facility / equipment / product/process.
- Team member for execution of validation of facility / equipment / product / process.
2. Documentation Control
- Controlled distribution and archiving of documents.
- Control of changes made by proper change control procedure.
- Approval of all documents.
3. Assuring Quality of Products
- Training on regulatory requirements
- SOP compliance
- Audit of facility for compliance
- Line clearance
- In-process counter checks
- Critical sampling
- Record verification
- Release of batch for marketing
- Investigation of market complaints
- Stability of products
4. Quality Improvement Plans
- Feedback received from the compliance team
- Proposals for corrective & preventive actions
- Annual products review
- Trend Analysis of various quality parameters for products, environment & water.