QUALITY ASSURANCE

Quality Assurance function assures compliance with cGMP/GLP requirements covering all matters related to the quality of the Product & Services offered by Premas. Focus is to ensure that the organization follows a standardized common quality system ensuring consistency, effectiveness and efficiency through:

Establishing and maintaining quality standards.

Developing processes to achieve those standards.

Monitoring to ensure compliance.

Internal audits for quality compliance to appraise the effectiveness and applicability of the quality assurance system.

Qualifications (DQ, IQ, OQ, and PQ) for new equipments along with periodic re-qualification and Process validation are conducted in accordance with predefined and approved protocols.

Periodic calibrations are performed for critical equipments.

PREMAS is directed by written policies, standard operating procedures and protocols for process harmonization and results reproducibility.

Methods are validated to satisfy customer requirements to fulfill regulatory aspects.

Vendors are assessed and evaluated in accordance with the GMP requirements and corporate policies to create conditions for adequate material availability and adherence to specifications.

Products are handover along with Certificate of Analysis and satisfactory arrangements exist for ensuring the storage, transport and subsequent handling of product to customer to maintain the quality throughout their shelf-life.

Imparting training to raise competency and continuous improvement on quality aspects.