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A Quality Management System (QMS) in the pharma industry is essential to ensure that products are consistently produced & controlled to meet the required quality standards & to comply as per the regulatory authorities.

✅ Quality Policy & Objectives:
The first step is to establish a clear quality policy that outlines the organization’s commitment to quality. Specific quality objectives are also defined to measure progress towards achieving these goals.

✅ Quality Manual:
The Quality Manual is a comprehensive document that provides an overview of the QMS structure, responsibilities, and procedures.

✅ Standard Operating Procedures (SOPs):
SOPs are detailed, written instructions that describe the specific steps to be followed in various processes.

✅ Document Control:
A robust document control system is established to manage the creation, revision, approval, and distribution of documents such as SOPs, protocols, batch records, and specifications.

✅ Training & Competency:
Employees involved in manufacturing, testing, and quality assurance undergo training to ensure they understand the procedures and are competent to perform their assigned tasks.

✅ Change Control:
Any changes to processes, equipment, materials, or systems that may impact product quality are carefully evaluated through a change control process.

✅ Risk Management:
A risk-based approach is adopted to identify, assess, & manage potential risks throughout the product life cycle.

✅ Supplier Quality Management:
Pharmaceutical companies work with various suppliers for raw materials, components, and services.

✅ Validation & Qualification:
Critical equipment, processes, & computer systems are validated & qualified to demonstrate that they consistently perform as intended & to meet predefined quality criteria.

✅ Non-Conformance & CAPA:
When deviations from established procedures occur or when quality issues arise, non-conformance reports are initiated & proper CAPA to be taken.

✅ Internal Audits:
Regular internal audits are conducted to assess the effectiveness of the QMS & identify areas for improvement.

✅ Management Review:
Top management periodically reviews the performance of the QMS and assesses its continuing suitability, adequacy, & effectiveness.

✅ Product Release and Batch Record Review:
Before a product is released for distribution, the batch record & related quality control test results are reviewed to ensure compliance with specifications and GMP requirements.

✅ Complaint Handling:
Procedures are established to handle customer complaints regarding product quality.

✅ Post-Market Surveillance:
Once a product is on the market, the QMS includes mechanisms to monitor its safety and efficacy.

✅ Continuous Improvement:
The QMS fosters a culture of continuous improvement, where data-driven decisions & feedback from various sources are used to make enhancements to processes & systems ensuring product quality & patient safety.


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