Relizon Places High Importance on the Product Quality.
as it directly affects the lives of patients. Typical problems with quality of a product can be:
- i. Discoloration
- ii. Broken or missing tablets
- iii. Melted capsules
- iv. Particles in solutions
- v. Cracked vials/bottles
- vi. Mislabeling (misprinted text, incorrect batch number or expiry date)
All manufactured batch undergo quality assurance check for each batch. Quality department draws sample, checks it against the quality parameters, and ensure that it is fit for sale/consumption.
All deviations are thoroughly investigated and the batch is rejected if deviations are significant. Sometimes, quality problem may not be noticed based on the sample and may surface later when the product has already reached the market. In cases, where an Adverse Drug Reaction (ADR), any issue related to quality or any other observable anomaly is reported by a patient or a Healthcare Professional (HCP), the companies are required to take immediate action and recall the product from the market. In such cases, DRAP, HCPs, pharmacies and public has to be informed about particular batch for recall.
Adverse Drug Reaction (ADR) is a critical process to ensure product safety, Pharmaceuticals companies provide telephone contact details and websites where anyone can lodge a product complaint or report a quality issue. Furthermore, a Root Cause Analysis (RCA) is carried out to investigate the issue and take corrective measures.
In some cases, the government regulatory body, i.e. the Drug Regulatory Authority of Pakistan (DRAP), may also notice significant issues related to quality and may initiate its own inquiry to check, whether any malpractices are involved.
In above scenarios Relizon’s Finance Executives ensures adequate investment in QA systems and equipment to ensure reliability of product quality. They have a regular interface with QA and Pharmacovigilance teams to ensure that potential sales return from ADRs reported are recorded as an estimated provision against sales return as soon as ADR is reported for any specific batch of the product.
