QUALITY MANAGEMENT SYSTEM

Our Quality Management system (QMs) at Dinlas Pharma ensures processes for methods, skills and controls in a consistent manner. QMs looks into any process issues or opportunities and works for continuous improvement.

We believe and work towards the manufacturing of quality products. This is supported by a well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe, effective and released only after thorough analysis as per stringent specifications, methods and procedures developed by QMs

The company complies as per the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GPVP), according to international guidelines such as viz. EU cGMP and WHO cGMP.

QUALITY CONTROL

Quality control is an essential part of the pharmaceutical industry’s primary process.

Our State of art Quality Control department is equipped with well calibrated instruments to do the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products so that reliable results are obtained.

The Quality Control department ensures compliance for analyzing that sampling and testing of all raw materials, packaging materials, intermediates and the finished products are tested as per good laboratory practices and Pharmacopeia specifications.

Sampling and testing of all the materials is done on each batch & the release of materials for use in production and the release of products for sale are done by the registered company pharmacist after ensuring that the products meets all the required specifications.

The QC department performs the following activities:

The Quality Control department ensures compliance for analyzing that sampling and testing of all raw materials, packaging materials, intermediates and the finished products are tested as per good laboratory practices and Pharmacopeia specifications.

Sampling and testing of all the materials is done on each batch & the release of materials for use in production and the release of products for sale are done by the registered company pharmacist after ensuring that the products meets all the required specifications.

• Raw Material / Packaging Material Analysis
• Finished Products Analysis
• In-Process Checks
• Stability Studies

The QC activities are managed through the following sections:

• Instrumental Analysis and Finished Products
• Microbiological Testing Laboratory
• Packaging Material Testing Laboratory

We strictly follow current good laboratory practices (c-GLP) with proper training, instruments calibrations / verifications, analytical method verification (AMV), good documentation practices (GDP), OOS, OOT and products stability study (as per ICH guidelines) followed by current controlled Guidelines / Pharmacopeia’s / Specifications / Protocols / STP.

Finally, Dinlas Pharma believes in working as a team to meet all expectations by committing to adopt and implement a strong Quality Management system.

Quality Statement

We are committed to consistent manufacturing and provision of superior pharmaceutical products therefore stringent process controls are inherent in our operations.

Production is run on strict accordance with International and Local Quality Management Standards and Systems.

We strive and conform to all local and international Regulatory bodies thereby providing pharmaceutical products of the highest quality.