Your browser is out-of-date!
Update your browser to view this website correctly. Update my browser now
Quality Control Laboratory having Staff for LVP & SVP Products. The Quality Control Lab has the testing facility with Instrumentation Section, Chemical Section, Stability and Packaging Material Section and a separate Microbiological Section for testing of MLT, BET and Environmental Monitoring as per regulatory and pharmacopeial requirement.
The Quality Control System is an integral part of cGMP and ensures that the necessary and relevant tests are performed. Quality Control Department is independent of Production Area. Quality Control Department has the responsibility and authority to approve or reject all Components, Drug Product Containers, Closures, Packing Material, labeling and Drug Products. Quality Control shall be concerned with Sampling, Specifications, Testing, Documentation, release procedure which ensure that the necessary and relevant test is actually carried and that the materials are not released for use or products not released for sale / supply until their quality has been judged to be satisfactory.
All instruments of the Quality Control Department are Calibrated and Analytical Procedure is validated. Periodical Calibration of Instrument and Validation of Procedures is carried out. Head Quality Control investigates and records the Out of Specification. Head Quality Assurance Investigates and Records all the Product Complaints. Each specification for Raw Materials, Intermediates, Finished Products and Packing Materials is maintained and checked by Quality Control and Final Approval by Quality Assurance Department.
A system is established for dealing with complaints that include written procedures indicating the responsible person(s) through whom the complaints are channeled. The responsible persons have adequate knowledge, experience and authority to decide the action to be taken.
All complaints concerning a product defect are recorded with all the original details and thoroughly investigated. The responsible person decides whether and what subsequent action is necessary. Based on the investigation subsequent Corrective and Preventive Action is taken.
Complaint records are regularly reviewed for any indication of specific and recurring problems requiring attention and possibly the recall of marketed Products.
Whenever complaints are received, the nature of complaint is recorded in the Complaint Book Register along with all other available details in Register. The complaint is investigated and evaluated thoroughly.
If a sample is accompanied with complaint the defect in the product / container / pack / is observed. Reference Samples / Control Samples are checked for visual inspection of particular batch. Depending upon the nature of Complaints particular tests are performed on Control Samples if required.
All the records pertaining to the Product, Batch No., Batch Manufacturing Record (BMR) and Analytical Control records are checked thoroughly for the particular complaint. An immediate action is taken for show cause notices of Drug Authorities. On investigation and evaluation, if the product recall is necessary, immediate withdrawal letter is sent to all the depots or stockiest. An appropriate follow up action is taken in case of product recall. Suitable replies to all concerned are made at an early date.
The Head QA & Head Production are responsible for handling the Product Complaints. Details are available in Handling of Product Complaint Log.
Recall refers to the removal of a specific batch or batches of the Product from the Market. The recall may be initiated by the manufacturer or the distributor either following the reports of adverse reactions or as the failure of ongoing Stability Studies or under the directions of the Regulatory Authorities. In case of Product Recall following procedures are adopted.
The purpose of recall is to ensure rapid and effective withdrawal of the drug from the markets, depots, stockiest, institutions etc. In case if any complaint received to avoid any untoward effects to end user (Patient). First of all determine
1. The reason of recall.
2. The degree of recall. (Type of complaint whether of serious nature or other external) damages to Product Container / Packs / Labels etc. These includes Sterility Failure / Severe Shivering, Anaphylactic Shocks or any other serious problems to any patient.
The Distribution Records are readily available to the person(s) responsible for recalls and contain sufficient information on wholesalers and customers (Addresses, emergency and ‘Out of Hours’ contacts and telephone numbers, batches and quantity delivered), including exported products and medical samples. Recalled products should be identified and stored separately in a secured area while awaiting a decision. The progress of recall process is recorded and a final report is to be issued that includes reconciliation between the delivered and recovered quantities of the products. Effectiveness of the recall is checked periodically to evaluate the recall process.
The purpose of Self-Inspection is to evaluate the compliance with GMP in all aspects of Production and Quality Control. The Self-Inspection program is designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-Inspections are performed routinely and on special occasions like product recalls, repeated rejections or any inspection by regulatory authorities.
Self Inspection Team is appointed by the Management from staff who are expert in their own field and familiar with GMP & cGMP requirements. The team consists of
The team responsible for Self-Inspection consists of personnel from cross-functional department who can evaluate the implementation of cGMP. All recommendations for corrective action are implemented.
The Procedure for Self-Inspection is documented and effective follow-up program is taken within a fixed time period for implementation of Corrective Action and Preventive Action. The Standard Operating Procedure is in place that defines frequency, Planning, Selection of Team, Execution and Reporting System.
Once in year.
Following checklist are included in routine Self Inspection Program:
Warehouse & Dispensing, Calibration of Instruments & Measurement Systems, SOP and Master Documents, Quality Assurance Department, Quality Control Department, Engineering Department, Human Resources Department, Water System, Building & Facility, Premises including Personal Facilities, Laundry, Computerized System including Software used by Warehouse, Production & Quality Control Department.
A report should be made after completion of Self Inspection. The report includes
Self Inspection Results, Evaluation and Conclusion, Recommended Corrective Actions.
Self Inspection Team evaluate Self Inspection Report and Corrective & Preventive Action Report.