Quality Policy

The Quality Management System of The Manufacturer

To ensure best quality system we implement systematic, consistent and efficient process for identification, assessment and review of risks related to the quality and compliance of the product.

All the necessary facilities for cGMP are provided including appropriately qualified and trained personnel, adequate premises and space, suitable equipment and services correct materials, containers and labels, approved procedures and instructions suitable for manufacturing testing storage and distribution.

Adore has endorsed Quality Policy and demonstrated its commitment to adhere to deliver Quality products through continuous Improvements in the system, procedure and processes.

Responsibilities of Quality Assurance Department : QA is responsible for maintaining total quality of systems and products as per WHO and cGMP requirements. Major responsibilities covers.
• Ensure compliance of WHO and GMP requirements.
• Approval and verify implementation of defined system and standard procedures.
• Ensure availability of approved procedures and specifications for reference.
• Review Batch manufacturing and testing records before giving product release.
• Review and authorized validation master plan and protocols.
• Ensure compliance of change control procedure.
• Ensure induction and training of employees as per calendar.
• Carry out process controls, including in-process checks/inspection/line clearance.
• Investigate complaints, deviations and quality incident.
• Handling of regulatory inspections at the site.
• Ensure the implementation of amendments in specifications and procedures as per current pharmacopoeia standards.
• Ensure the implementation of pest and rodent controls, as per defined schedule.
• Review product stability reports.
• Review batch manufacturing record, verify reconciliation of batch inputs, batch yields and finally release the products.
• Document control.
• Annual product quality review.
• To review SOPs related to the quality assurance and manufacturing sites.

Release Procedure of Finished Products

Finished Goods are released by Quality assurance. After analysis of batch by quality control department, a certificate of analysis is generated which is approved by Quality Control In-charge. The Batch Manufacturing Record and Analytical records are reviewed by Quality Assurance. The Quality Assurance Department check the finished goods. After that Quality Assurance will issue the Release slip to Bonded Store In-charge and only after the release slip the bonded store In-charge will dispatch the batch from the factory.

Management of Suppliers and Contractors

We have Approved Vendor list for all the APIs and Excipients used in the formulations. All the APIs and Excipients are tested with the approved specifications (IP/BP/USP or In-house Specifications)

Company uses outside expertise for Area validation, Calibrations, Analysis of all raw materials and finished products is carried out at the site by our own trained quality control staff. However, analytical services of the following external approved laboratories are utilized for the specific tests.

Quality Risk Management & Product Quality Review

We follow a systemic process for the assessment, control, communication and review of risk to quality of the product during product shelf life

We have the system for annual product review for products manufactured at the site every year as per SOP No. Each batch is reviewed by Quality Assurance for completeness of raw material, yields, and deviations, Analysis result(COA).