PNN
New Delhi [India], November 3: Medicine quality plays an important role in determining the safety of patients and consumer confidence in the brand. Medicines have to undergo multiple tests that ensure their quality, safety, and efficacy. A medicine must pass through the standardised limits set by the regulatory authorities of a particular region.
Zee Laboratories is a company established in 1993 in Karnal, India. The company has been serving the people of India for the last 33 years, gradually building trust both in India and abroad. The company has served more than 3 million active consumers and deals in more than 5000 products, spanning medicines to everyday lifestyle and healthcare. The company has been manufacturing under the WHO-GMP guidelines to consistently ensure the quality and safety of its products.
Zee Laboratories has been manufacturing medicines through in-house manufacturing plants. The company places special importance on testing and verification of the quality reports for its products. Zee Laboratories follows a stringent quality management system that helps in maintaining the quality of its products from raw materials till they reach the end consumer.
Regulatory Compliance, Certificates and Pharmaceutical Quality Standards
Regulatory authorities such as CDSCO, NPPA, PCI, FSSAI, SLA and FDA govern every pharmaceutical company in India. These authorities ensure that proper manufacturing conditions are maintained for various medicinal products, as well as for their pricing, distribution, and pharmacovigilance.
Zee Laboratories have been granted approvals and certifications from WHO-GMP, FDA, ISO, SLA, HACCP, SGS-quality (9001), and FSSAI. These certifications act as self-sustaining proof of the medicine quality produced by the company. The company places special focus on controlled manufacturing procedures, trained personnel, suitable premises, equipment maintenance, sanitation, and documented quality checks.
These measures help to reduce the risk of contamination, mix-ups, production errors, and variations between batches. Following these procedures also supports consistent manufacturing and reliable evaluation of finished products.
Quality Checks During the Manufacturing Process
Maintaining the quality of any medicine is not a single-step process. It requires thorough monitoring during the entire process from buying raw materials to distributing the finished product. Zee Laboratories performs quality checks at multiple stages to ensure that only safe medicines reach consumers.
These quality tests are planned, calibrated, and evaluated as per industry norms and set regulatory standards. The quality tests are performed as per the dosage and the medicine being made. This process makes it important for different products to qualify individually in their product category, ensuring safety standards for each product.
These quality checks can be further subdivided into three stages – raw material testing, in-process testing and finished product testing.
Raw material testing
Zee Laboratories performs raw material testing as soon as the material is obtained from the vendor. These tests involve confirming the API identity, checking for the purity, strength, and suitability for producing a particular formulation.
Once the purity and strength of a raw material are confirmed through in-house testing, it is sent for further processing or stored in the temperature- and moisture-controlled warehouses.
In-process testing
The company performs in-process testing by randomly sampling a few units from a batch to ensure uniformity in different parameters. The number of samples may depend on the type of product, test, and number of total units in a single batch.
These tests commonly involve weight variation, assay, physical traits of the product, adulteration, microbial limit tests, and BET. These tests are performed in an individual batch testing protocol that helps in ensuring consistent quality throughout all the batches.
Finished product testing
Once the manufacturing of a batch is complete, the company selects a few units randomly and then tests them to check if they pass the standard criteria set by the regulatory authorities. The protocol for finished product testing is similar to the in-process testing.
Once the products pass finished product testing, they are set for release. Individual batch documents are then made to help trace the product after release.
Batch documentation and traceability
Documents such as Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), COAs, and other quality-relevant documents are verified before making a product available to the consumer.
Packaging, Stability, and Product Quality Monitoring
Managing the quality of medicines is an in-depth process that is carefully performed at all stages of the production of any medicine. It also involves managing the packaging of each product, as the packaging requirements differ for each product. Packaging integrity is specifically important to ensure that the product reaches the consumers safely.
Zee Laboratories has an extensive system for conducting stability tests for its wide range of products, as it determines the shelf life of any product. The company runs both real-time and accelerated studies to better analyse the stability of its manufactured products.
The company ensures proper packaging and checks for clear labelling of the manufacturing date, batch number and expiry date. This helps consumers understand that the product is safe for use and may help the company track its batch in case of any complications.
Zee Laboratories Commitment to Quality and Patient Safety
Zee Laboratories runs an extensive network of manufacturing units that cover more than 5000 healthcare products. The company has been accredited with necessary quality certifications from WHO, FSSAI, SGS, HACCP and FDA. This is an evident record of the company’s diligent efforts in maintaining quality and serving people.
The company performs routine audits at multiple levels to test and verify the quality of its medicines and medicinal products. Zee Laboratories has been serving people with quality for 33 years and aims to provide safe and genuine medicines for its consumers.
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