Quality Assurance & Quality Control

The manufacturing unit equipped with latest high precision instruments, Alka Laboratories has made all efforts to raise its quality standards to international levels. Quality Assurance / Quality Control plays a very important role in making sure that the GMP standards are met and products comply with the international quality standards. The main functions carried out by this department are as under:

• Approval of raw materials
• Monitoring of manufacturing processes.
• Approval of finished products
• Documentation of technical information
• Study of process and product patents.
• Implementation of cGMP

Quality Assurance Department has an excellent team of professionals having good understanding of concepts of quality systems and cGMP. Manufacturing processes are monitored and controlled by testing of raw materials, in-process parameters.

Final active pharmaceutical ingredients are tested for specified parameters before release. Analytical testing is carried out with highly sophisticated instruments viz. HPLC, GC, IR, UV spectrophotometer,Titrators, Particle size analyzer etc. Records of manufacturing are properly documented.

All the analytical test procedures and manufacturing procedures are well documented and revision is undertaken as per specified protocol. Analytical methods are validated to give the reproducible results. Stability study as per stability protocol is considered to be very important area of Quality Assurance.

In our efforts to continuously improve and expand, our plant has been approved by ISO 9001:2015 and State GMP Regulatory Authority.

Our Quality Policy Is:

Alka Laboratories Pvt. Ltd. shall work towards a common goal of achieving total customer satisfaction and confidence and continually improving effectiveness of Quality Management System by Developing, Manufacturing and Supplying Bulk Drugs (APIs), for Domestic and International Market with Quality, Speed and Technical support while meeting applicable statutory and regulatory requirements. This responsibility and commitment is practiced and communicated by top management through:

a) Implementing a system, which meets the latest Quality Management Standard ISO 9001:2015, GMP as well as Pharmacopeial / Regulatory requirements, Industry Standards that can be clearly understood, managed and improved in effectiveness as well as efficiency;

b) Ensuring empowerment of people to deliver products which meet customer needs and expectations, and also provide continual improvement;

c) Establishing and pursuing Quality Objectives and performance standard;

d) Reviewing of the suitability of Quality Policy by conducting Management Reviews”