We at Oceanic Pharmachem Pvt Ltd, have designed & developed our Quality Assurance System which encompasses all applicable elements of ICH Q7A.
Adherence to Quality Agreements:
Oceanic Pharmachem Pvt Ltd believes in long term association with its business partners. In order to maintain the clarity in the Quality attribute requirements Oceanic Pharmachem Pvt Ltd enters into Quality Agreement with its partners and ensures that the requirements of the Quality Agreements are fulfilled at all the time.
In our endeavor to meet customer quality requirements we select our suppliers with utmost care to ensure that the supplier is capable of consistently supplying right quality products. We follow a well-defined Supplier Qualification process which includes Supplier Self-Assessment, Pre and Post Approval Quality Audits and Periodic Qualification. The entire process of Supplier Qualification is carried out in concurrence with customer.
Stringent and Systematic controls on product release:
For Oceanic Pharmachem Pvt Ltd objective is to consistently supply right quality products to the customers. We exercise additional control to meet our objectives. After product is approved by manufacturer, Oceanic Pharmachem Pvt Ltd’s personnel visit the site of manufacturer who is well trained to inspect & check the consignment as well as sample the product. The inspection is carried out as per predetermined checklist which includes Storage Conditions, Inspection of Containers, Labels, Lids, Closers, etc. Oceanic Pharmachem Pvt Ltd’s personnel prepares batch wise composite samples in 3 sets wherein 1st sample is sent to customer for pre-shipment sample evaluation, 2nd set of sample sent to testing laboratories to ensure the results are matching with customer’s specification & 3rd set of sample is kept with Oceanic Pharmachem Pvt Ltd as reserve sample for future purpose. The containers are sealed and the consignment is secured by isolating. Once the approval is received from the testing Laboratories and Customer, the consignment is re-inspected for the damage to the Containers, Labels or Seals and the Certificate of Analysis is prepared. After the final inspection the consignment is dispatched along Certificate of Analysis and all other regulatory and statutory documentation.
Storage of product is one of the critical activities in the Supply Chain Management. To avoid mix-ups and loss of product identity or purity, we exercise controls from product receipt, storage, and dispatch with the aid of various checklists. Product requiring special storage conditions are stored as per requirements and records are maintained for the same. Oceanic Pharmachem Pvt Ltd personnel confirm storage conditions when they go for sampling to the manufacturer’s premises.
Traceability of Distributed APIs and Intermediates:
Traceability of the products is very important in case of any eventuality. We retain all product consignment related documents like; Certificate of Analysis, transportation documents, statutory and regulatory documents, all inspection checklists and any other related document as per the regulatory guidelines.
Our Quality Agreements stipulate the requirement of Quality and Regulatory information to be shared with the customer. Some of the information like; Process Description, Specification, Test Methods, Labeling requirements, etc. are shared before start of the business and are updated as and when needed. The batch wise information like; Certificate of Analysis, packing list, etc. is provided along with each consignment.
Quality Assurance Department is responsible for management of Customer Complaint. Oceanic Pharmachem Pvt Ltd aims for ZERO Customer Complaint and puts in all its’ efforts to achieve it. In spite of all our efforts, if we receive any Customer Complaint, we manage it with a defined procedure. When we receive the complaint, we register and review the nature of the complaint. If complaint is Quality or Quantity related then the details are passed on to Manufacturer for the Root Cause Analysis and Corrective / Preventive Action. Logistic and Commercial complaints are investigated at Oceanic Pharmachem Pvt Ltd. Once the Root Cause is determined the appropriate Corrective / Preventive Actions are finalized. In both the cases customer is informed about the complaint investigation along with Root Cause Analysis and Corrective / Preventive Actions. After getting consensus from the customer, the complaint is closed. The effectiveness of Corrective / Preventive Actions is monitored by checking recurrence of the similar complaint.
Handling of Returned Material is a critical cGMP aspect. We maintain the Records of returned product. The record include, Name and address of the customer, Name & address of the manufacturer, name of the product, batch number and quantity, reason for return, and disposal of the returned product. Upon receipt the returned product is clearly identified / labeled and isolated. The manufacturer is informed about the incident and after completing all statutory and regulatory requirements the product is securely transported to the manufacturer. The Returns are investigated as per the Complaint handling procedure.
Change Management is one of the major clauses in our Quality Agreements. Manufacturer seeks the Customer approval for any Major or Critical Change before implementing. Manufacturer follows the Change Control Procedures prevailing at their end and Customer evaluates the merit of the Change and approves or rejects the Change. If approved and if warranted Customer completes the registration change control formalities.
Self – Assessment:
Self-Assessment or Internal Audit is powerful tool to evaluate the Quality System. We conduct periodic Internal Quality Audits. The outcome of the audit is reviewed in the Management Review.
Senior management of Oceanic Pharmachem Pvt Ltd periodically reviews the Quality Management system to ensure its’ suitability, adequacy and effectiveness. The review includes the assessment of opportunities for improvement and any potential changes to the Management System, including quality policy and objectives, and their alignment with business objectives and strategy. Customer Complaints and Audit outcomes are also reviewed during the meeting.
In Oceanic Pharmachem Pvt Ltd we have a strong belief that the Training and career development are very vital for our growth. Training is essential for building an efficient, effective, and highly motivated team, which enhances company’s competitive position. We conduct various job specific and management skill training programs for our employees.