Discussions

Pharmaceutical manufacturing under a third-party pharmaceutical company is carried out on a contractual basis, in which brand owners contract with manufacturing plants that are certified to produce their products. Although this model saves on infrastructure and opens up the commercialization process, quality control is a pillar of successful partnerships. The product is subjected to a stringent and multi-layered quality system that makes sure that all products are subject to regulatory, safety, and efficacy standards before being allowed to reach the market.

Vendor Qualification and Verification of Compliance.

• The quality control starts with the choice of a manufacturing partner.
• It needs GMO certifications, manufacturing permits, and regulatory authorizations to be verified.
• The assessment of historical audit data, inspection history, and technology infrastructure makes sure that it is evaluable.

Quality Assurance of Raw Materials.

• Active Pharmaceutical Ingredients (APIs) and excipients are tested in terms of identity, purity, and potency in each batch.
• A check of packaging materials is made on the grounds of their durability and labeling.
• Approved materials are only provided that are based on predefined specifications and sent into production.

Normal Operating Procedures (SOPs) and Batch Validation.

• SOPs are documented in all the production and testing activities.
• Process validation will make sure that manufacturing processes do not produce products of sub-standard quality, given the needed characteristics of quality.
• Manufacturing batches have records that give an accountable record of process compliance.

Laboratory Assessment.

• Finished products are thoroughly tested, whereby assay, microbial, and stability tests are undertaken.
• The analytical methods are characterized by validates that determine the strength of the products, safety, and adherence to the pharmacopeial standards.

Shelf-Life Confirmation and Stability Studies.

• Accelerated and real-time stability tests are aimed at testing how the product performs under various environmental conditions.
• Such researches make the medicines safe and effective during the labeled shelf life.

Documentation Control and Traceability.

• The data collected on the raw materials, the logs in the production, the test report, and the distribution records are kept.
• Good traceability systems would help to manage recalls in case of necessity.
• Internal audits, once in a while, enhance the accuracy of documentation and compliance with the rules.

The Quality-Oriented Third-Party Manufacturing Strategy of Jamkas Pharma.

• Jamkas Pharma is also keen on agreeing with certified GMP-compliant manufacturing plants.
• Conventional audit of purchasing vendors, frequent quality review, and well-spelt quality agreements maintain uniformity.
• Compliance integrity is ensured by comprehensive documentation systems and regulatory practices.
• Jamkas Pharma has developed safe, reliable, and high-quality pharmaceutical products by using its iron grip of quality control mechanisms at each phase through a third-party manufacturing network.