Quality Assurance (QA / QMS) | General Drugs House Co., Ltd.

Overview Quality Control (QC)Quality Assurance (QA / QMS)Validation · Stability Quality team

The Quality Management System (QMS) covers quality assurance of drug products, the validation master plan, change control, deviation control and quality risk management, together with batch records, recall, returns, customer complaints, media fill & environmental monitoring, process/cleaning validation, product quality review, stability and the water system.

Quality assurance of drug product

Objectives: study stability and set expiry · monitor stability of products with assigned expiry · verify manufacturing, cleaning and packing · assure quality before release.

1Study stability of the product to be registered

2Regulatory affairs registers the formula

3First-production verification (validation master plan and documents)

4Assess the environment of production areas

5Approve transfer to finished-goods warehouse

6Post-market quality assurance

Validation master plan (VMP)

Describes the equipment, systems and methods that require validation and the responsibilities involved — covering critical systems, processes and equipment, assessed by (1) direct impact on quality and safety, (2) direct product contact and (3) risk assessment.

Qualification planProcess validation planComputer system validation planCleaning validation planAnalytical method validation plan

Change control

A system that reviews proposals or changes that may affect product quality, keeping traceable records and assuring quality stays within standard.

1Request approval for the change

2Implement the change

3Follow up and evaluate the change

Deviation control

Control of deviations during production from the set standard or plan; each must be evaluated and approved by QA.

1Request deviation (production / packing / related units)

2Risk assessment (related units and QA)

3Corrective action plan (section head)

4Carry out the plan (responsible person)

5Conclude product status (QA manager)

6Sign off to close (section head, production and QA managers)

Quality risk management (ICH Q9)

A systematic process for assessing, controlling, communicating and reviewing quality risks throughout the product life cycle and prioritising them, following ICH Q9.

Batch production release

1Final check: product name, lot no., Mfd./Exp., address, quantity in quarantine, correct packaging and printed materials

2Send production records to the QC manager for review

3Issue the Certificate of Analysis, checked by the QC manager

4QA manager evaluates release from batch records and analysis results

Release criteria: complete raw materials and correct weighing · process conditions within limits · batch and packing records complete and correct · in-process results within criteria · Certificate of Analysis meets specification · correct containers · QC final check correct.

Recall product

Objective: fast, effective recall that protects consumers promptly and reduces the chance of harm.

1Receive the quality-problem report

2Assess the problem (QA manager)

3Investigate root cause (QA and marketing)

4Recall the product

5Destroy the product

Recall ordered by the FDA

An appointment with officials is required to supervise destruction.

Voluntary recall

Destruction proceeds without an appointment; evidence with photos is submitted to the FDA.

Returned product

Manages returned and damaged products so that returns are never mixed with finished-goods stock.

1Receive returns from the customer and log them

2Initial assessment per the returns decision table

3Maintain the returned-goods room

Customer complaint

Complaints are used to improve product quality, delivery and service, handled efficiently and effectively to build customer satisfaction.

1Customer finds a product defect

2Complaint received by the company

3Investigate, correct and prevent

4Approve and report findings to the customer