Skip to main content

Quality Assurance

Quality Policy

Quality policy, procedures & processes, self inspection audit program, review mechanism of the quality system, Quality risk management, annual product quality review and release for sale procedure for finished product.

We Skylark Pharmaceuticals Pvt. Ltd. are committed to-

  • To ensure that every product manufactures & distribution with consistent quality, efficacy & safety with present standards as per current GMP standards.
  • Excellence in products, process and systems are to be achieved through the team effort of trained personnel of the company.

To provide best quality products to patient by following cGMP practice at every level of manufacturing as per latest international guidelines and continuous improvements.

Quality Management System

Skylark has a well-planned quality management system.

All the raw materials and packing materials are procured from approved vendors.

All the materials, sampled by QC personnel as per SOP are tested and approved or rejected by quality control department.

Materials are tested as per the current approved standard test procedures.

Rejected materials except printed packaging materials is segregated and returned to the Supplier or destroyed. Printed packaging material is destroyed in the premises as per SOP.

Approved materials are stored as per the prescribed storage conditions.

Only approved materials are issued to Production.

Reserve samples of all raw materials are maintained as per SOP.

The Production/Process areas are checked and cleared for production by quality assurance personnel.

The production operations are inspected by QA personnel.

The physical tests like hardness, weight variation, thickness, disintegration test etc., are carried out by Production/QA Personnel.

The in-process sampling is carried out by QA personnel.

All the in-process samples and the final products are tested as per approved and validated methods and specifications by Quality control.

Quality control gives the results of analysis as per specifications.

Analytical and batch manufacturing records are reviewed by quality assurance.

Quality assurance will release the approved product batches after verifying all the records and cGMP compliance.

Quality control department responsible for the analysis and approval of raw materials, packaging materials, and finished products.

Quality Assurance has the final authority in the approval or rejection of any input into the product or associated directly with the product.

UV

PH Meter

FTIR

Stability Chamber

QA QC Team