Quality Management Systems
Quality Management System
Olefia Biopharma Ltd. matches the GMP standards set by WHO and ISO-9001:2000 There are well-established Quality Management System in the organization including identification and control of requisite documentation and records.
The purpose of the Quality Management System is to ensure compliance of cGMP requirements as enforced by National and International Regulatory bodies. The Quality Management system ensure that all activities related to manufacturing of Drug Products in compliance with cGMP are controlled by Standard Operating Procedures, so that the end product meets all the Predefined Specifications ensuring the identity, strength, safety & purity of the Products.
Quality Management system controls the all operative and support system by the following elements.
All departments are audited internally for cGMP / cGLP compliance. The audit is conducted by an audit team comprising of competent persons from different departments, other than the department to be audited. The audit is carried out as per the SOP for self-inspection & audit reports recorded in a defined format.
Audit finding reports are made for which the concern department makes the compliance report. And the copy of it is sent to the Head Technical Operations for his review & comments.
Vendor Assessment / Development
Vendors of all active pharmaceutical ingredient as well as excipients and packaging materials are assessed by Material specification, Vendor pre purchase sample evaluation, vendor trial order for stability batches, Vendor approval and certifications etc.
Release of finished product for sale and distribution
After completion of batch manufacturing, packing and testing activity, Quality Assurance review the batch manufacturing, batch testing and batch packing record thoroughly along with all the process supporting documents. After confirming all the parameters found to meet standard Quality Assurance Manager Quality Assurance issue Batch Release Certificate to the distribution department to sale and distribute the batch.
Approval and Rejection of Raw and Packing Material
Each consignment of material received is initially examined by visual inspection to check the container condition, damaged condition, and proper labeling.
On verification of quality received and batch wise segregation, the details of receipts are fed into inward register and the Goods Receipt Note (GRN) is generated with unique serial number.
All the containers are placed in designated area labeled as QUARANTINE/ under TEST with details of GRN No. of containers, manufacturer name, and material code No. etc.
Samples are drawn and analyzed as per sampling plan for active material. All 100% containers to be sampled and for excipient Ö n+1 container taken for sampling after, sampling the sample analyzed as per established specification and then it decided that material meet to specification or not.
If material found meet to specification it labeled as “ APPROVED” and in case the material not meet the specification with respect to any parameter it labeled as “REJECTED” and kept separately specified REJECTED AREA the access of rejected area control by Quality Assurance Head. All packaging materials are handled as same as for raw material.
Control of Manufacturing Operations
Dispensing of raw and packing material is done as per SOP on FEFO and FIFO principle.