SOP for Job Responsibility of Quality Assurance Personnel

OBJECTIVE

To describe the procedure for defining the role and responsibility of the Quality Unit.

SCOPE

This SOP is applicable to define the responsibility of the Quality Assurance and Quality Control department.

RESPONSIBILITY

All Staff – QA

All Staff – QC

QA Manager

PROCEDURE

Principle

• The holder of a Manufacturing Authorization must manufacture medicinal products to ensure that they are fit for their intended use, comply with the marketing Authorization requirements and do not place patients at risk due to inadequate safety, quality or efficacy.
• The attainment of the quality objective is the responsibility of plant management and requires the participation and commitment by staff in all departments and at all levels.
• The quality Unit comprises of two departments i.e. Quality Assurance department and the Quality Control department.

Quality Assurance

• QA is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a product.

Quality Control

• QC is that part of GMP that is concerned with sampling, specifications, testing, organization, documentation, and release procedure which ensures that the relevant tests are carried out and materials are not released until the quality has been found to be satisfactory.

Responsibilities of the Quality Assurance Department

• To ensure the presence of quality policy and quality manual.
• Preparation of Validation Master Plan.
• Preparation of Site Master File.
• Preparation of Annual Product Quality Review.
• Handling of Market complaints, return goods, and product recalls.
• Qualification of Vendors
• To conduct self-audits as per the defined schedule.

Material Management

• To ensure procedure for indent, receipt, storage, and issuance of material as per defined procedure and cGMP requirements.
• Verification of Finished Product Dispatches
• Medicinal products are not sold or supplied before certification that each batch has been produced in accordance with the requirements of Marketing Authorization and any other regulations relevant to the production, control, and release of medicinal products.
• Satisfactory arrangements to ensure that medicinal products are stored, distributed, and subsequently handled so that quality is maintained throughout their shelf-life;

Process Control

• Review, approval and rejection of change controls.
• Review, approval and rejection of incidents.
• Review, approval and rejection of deviations.
• Preparation, Review and approvals of Qualifications (DQ, URS IQ, OQ, PQ)
• Preparation, Review and approval of Process validations.
• In-process checking of products and line clearance.
• Review and approval of failure investigations.
• Review and approval of reprocessing and rework.
• Approval of online rejections and material return notes
• Review and approval of Manufacturing Instructions.
• Storage and recording of control samples.
• Review and approval of CAPA.
• Review and approval of artworks and shade cards.
• Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
• Medicinal products are designed and developed in a way that takes into account of the requirements of GMP and GLP.

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Training

• Induction Training
• SOP training and on job training
• CGMP training.
• Training related to quality management system.
• Contract Worker Training
• External Training

Document and Data Control

• To retain a master copy of all the documents.
• To issue and retrieve a controlled copy of the master documents.
• To issue an Un-controlled copy of the master documents.
• To issue and retrieve log books.
• To Prepare, review approval and revision of SOPs of QA department and approval of SOPs of other departments.

Batch Release Function

• Prepare Review and approval of BMR and BPR.
• To issue BMR/BPR.
• Review of BMR/BPR and raw data sheet before release.
• Review of COA.
• Approval of batch through QA batch release intimation slip.

Audit and Compliance

• To conduct Self-Inspection or quality audits, regularly appraise the effectiveness and applicability of QA system.
• To prepare audit reports and monitor compliances
• To prepare for external (regulatory and customer) audits.
• To prepare responses to external audits and monitor compliance.

Equipment Management

• To ensure usage of only qualified equipment for production.
• To ensure calibration of equipment and instruments as per plan.

New Product Introduction

• To ensure analytical method validation, specification and STP, stability protocol, cleaning validation method, master formulation record, product specification, batch manufacturing record and batch packing record before starting a new product.

Product Identification and Traceability

• Batch numbering system.
• Unique identifying system for incoming material.
• Traceability of Material during Production.
• Labeling procedure.
• Equipment coding and status labeling.

Purchasing

Approved vendor and supplier listing.

Third-Party Jobs

Audit of outside labs for analytical testing.

Annual Product Quality Review

• Regular periodic reviews of all licensed medicinal products should be conducted to verify the consistency of the existing process and the appropriateness of current specifications.
• Such reviews should normally be conducted and documented, and should include at least:

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1. Review of starting and packaging material used for the products;
2. Review of finished product results;
3. Review of all batches that failed to meet established specifications and their investigation;
4. Review of all significant deviations or incidents, their related investigations, and the effectiveness of resultant CAPA taken;
5. Review of all changes carried out to the processes or analytical methods;
6. Review of all quality-related returns, complaints and recalls and the investigations performed at the time;
7. The qualification status of relevant equipment and utilities.
8. Review of technical agreements to ensure that they are up to date.

GMP for Medicinal Products

The basic requirement of GMP is that

• All manufacturing processes are clearly defined, and shown to be capable of consistently manufacturing medicinal products complying with their specification;
• Critical steps and changes in the process are validated;
• All necessary facilities for GMP are provided including:
• Qualified and trained personnel;
• Adequate premises and space;
• Suitable equipment and services;
• Correct materials, containers, labels;
• Approved procedures and instructions;
• Suitable storage and transport;
• Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
• Records are made, manually or by recording instruments, during manufacture to demonstrate that all steps defined in the procedure and quantity are taken. Any significant deviation is recorded and investigated;
• Records of manufacture enable the complete history of a batch record to be traced, and are retained in accessible form;
• A system is available to recall any batch of product, from sale or supply;
• Complaints about marketed products are examined, causes are investigated and appropriate measures are taken to prevent reoccurrence.

Responsibilities of the Quality Control Department

The basic requirements of QC are:

• Adequate facilities, trained personnel and approved procedures are available for sampling, inspection and testing starting materials, packaging materials, intermediate, bulk and FP;
• Test methods are validated;
• Records are made, manually or by recording instruments, which demonstrate that sampling, inspection and testing procedure were actually carried out. Any significant deviation is recorded and investigated.
• FP contains active ingredients complying with the qualitative and quantitative composition of marketing Authorization, are of purity required, and enclosed in proper containers with correct labels.
• Records are made of results of inspection and testing of materials, intermediate, bulk and finished products is formally assessed against specification.

Good Laboratory Practices and Equipment: 

Ensure that lab carries out its testing, calibration, validation, and all other technical activities in such a way as to meet GLP requirements.

Premises:

The laboratory shall be designed, constructed, and maintained so as to:

• Prevent entry of insects and rodents besides cross-contamination;
• The interior surface shall be smooth and free from cracks and permit easy cleaning and sanitization;
• Provision made for the space, equipment and also for utilities like water, power, and gas; air ventilation system;
• Tabletop shall be constructed with alkali, acid and solvent-resistant material and shall be smooth and free from services as far as possible;

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Personal:

• Staff in the lab shall possess the necessary qualifications, and proper training and shall have adequate experience for the assigned duties.
• Ensuring the control and maintenance of documents including the quality system as per the requirements of regulatory authorities which involve all raw data, SOPs, documentation protocols, etc.

Equipments:

• Instruments requiring calibration shall be calibrated at regular intervals and records shall be maintained.
• The instruments, instrument bench and surrounding areas shall be kept clean and tidy all the time.
• Glassware such as burettes, pipettes and volumetric flasks shall be calibrated. Weight boxes and thermometers etc. shall also be calibrated.
• Autoclaves must meet the requirements described for operations, safety and validation procedure.
• Work involving the evolution of harmful and obnoxious vapors shall be carried out in a fume hood.

Chemicals and Reagents:

• The storage and handling of chemicals and reagents shall be done in a manner that considers the physiochemical properties of these substances and the hazards involved in their use.
• All reagents and solutions shall be identified with a label.
• Containers of stock solutions and standard solutions should bear the name of an analytical chemist who prepared the solution, the date of preparation, use before the date, and the strength of the solution.

Good housekeeping and safety:

• Standard Operating Procedures for safety, house-keeping shall be prepared in accordance with various rules, and regulations of Government of India and include the following requirements;
• Drinking, eating and smoking shall not be permitted in the laboratories; food for human consumption shall not be kept in working or storage areas;
• Staff must wear laboratory coats or other protective clothing including gloves and mask;
• The laboratories shall have firefighting equipments and eye washer. Protective precautions to be taken in Laboratories
• Safety Shower shall be installed;
• Rubber suction bulbs must be used on pipettes; Appropriate facilities for the collection, storage, and disposal of wastes shall be made available;

• Staff must be aware of methods for safe disposal of corrosive or dangerous products;
• A standard operating procedure for handling, collection, disposal of chemical and biological wastes be prepared.
• Maintenance, calibration and validation of all instruments, equipments and other devices used in the laboratory.
• Reference materials are necessary for testing, calibration, validation and verification of a sample or of equipment or other devices and all such materials shall be traceable to an agency authorized by the Government of India or any other international body.
• The laboratory shall prepare working standards by comparing them with the reference standards and shall be routinely checked for their purity.
• Standard Operating Procedures for the maintenance of microbial culture and sub-culture must be prepared by the laboratories. All activities are carried out under Laminar Airflow.
• Raw data refers to the laboratory worksheet, notebooks or analysis sheet, records, memorandum, notes or extract copies that may be results of observations and other activities shall be maintained. Data integrity and security shall be maintained and data shall not be accessible to any unauthorized person.

ANNEXURE

Nil

ABBREVIATION

SOP:     Standard Operating procedure

QA:      Quality Assurance

QC:      Quality Control

GMP:   Good manufacturing practices

cGMP:  Current Good manufacturing practices

DQ:      Design Qualification

URS:    User Requirement Specifications

IQ:        Installation Qualification

OQ:      Operational Qualification

PQ:       Performance Qualification

CAPA: Corrective and Preventive Action

GLP:    Good Laboratory Practices

STP:     Standard testing Procedure

COA:   Certificate of Analysis

BMR:   Batch manufacturing record

BPR:    Batch packaging record

FP:      Finished Product

REVISION HISTORY

Nil

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