In an audit of the quality management system documents of pharmaceutical companies, the consultant DST found that there were some problems in the development of quality manuals for pharmaceutical companies:

Ø Incomplete content, quality risk management (QRM), change and other key quality management elements are not formulated;

The length is long and repetitive, and contains SOP for management procedures such as "personnel training" and "environmental monitoring;

Incomplete distribution of process responsibilities of quality management system: QA and Production Department are the only functions of process responsibilities of quality management system such as DV and CC;

Lack of equipment management, lack of risk assessment, etc;

Ø Lack of CQA and CPP, OOS/OOT description;

Lack of technology transfer and customer satisfaction (complaints, deliveries, recalls);

Lack of product annual review (APR) system quality review and analysis, etc.

The quality manual of pharmaceutical enterprises is a programmatic document, an important document to guide enterprises to establish and implement quality management system, its importance can not be ignored, it plays a vital role in ensuring the quality, safety and effectiveness of drugs:

Ø Clear quality policy and objectives:

The quality manual defines the quality policy and objectives of the pharmaceutical company to ensure that all employees have a clear understanding of the quality requirements. This helps to form a unified quality awareness and promote full participation in quality management.

Ø Standardize the quality management system:

The quality manual is a programmatic document of the quality management system of pharmaceutical enterprises, which describes in detail the organizational structure, responsibilities, procedures, processes and resources of enterprise quality management activities. It standardizes the quality management activities of enterprises and ensures the effective operation of the quality management system.

Ø Ensuring drug quality and safety:

The quality manual stipulates the quality control requirements of pharmaceutical enterprises in the procurement, production, inspection, storage and transportation of raw materials to ensure the quality and safety of drugs. By strictly complying with the requirements of the quality manual, enterprises can reduce the risk of drug quality problems and ensure the safety of patients.

Ø Enhance corporate image and reputation:

Having a complete quality management system and quality manual is an important means for pharmaceutical companies to demonstrate their management level and product quality. A company with a high-quality manual is more likely to gain the trust and recognition of customers, thereby enhancing the company's image and reputation.

Ø Meet regulatory requirements:

The pharmaceutical industry is a highly regulated industry, and governments and regulatory agencies have formulated strict regulations and guidelines for pharmaceutical companies to follow. As the core document of the quality management system of pharmaceutical enterprises, the quality manual must meet the requirements of these regulations and guidelines. By developing and implementing quality manuals, companies can ensure compliance with relevant regulatory requirements and avoid legal risks and penalties.

Sustained improvement and upgrading:

The quality manual not only stipulates the quality management activities of pharmaceutical enterprises, but also provides methods and ways to continuously improve and enhance quality. Through regular review, internal audit and external audit and other means, enterprises can find the problems and deficiencies in the quality management system, and take effective measures to improve and enhance.

Durst (DST) consultants for pharmaceutical companies to better write a good quality manual, to give you real dry goods, first launched the quality manual covered by the content, the quality manual covers all aspects of the pharmaceutical plant, including but not limited to the following:

1. Cover and Catalogue

Ø The cover shall include the name of the enterprise, the title of the manual, the version number, the date of preparation, the approver and other information.

Ø The table of contents should list the main chapters and sub-chapters of the manual for easy access.

2. Introduction

Ø Briefly introduce the purpose, scope, preparation basis and applicable object of the manual.

Emphasize the importance of quality in pharmaceutical companies and the role of quality manuals in guiding corporate quality management.

3. Company Profile

Ø Introduce the basic information of the enterprise, including historical evolution, business scope, main products, etc;

Ø Organizational structure;

4. Quality Management System

4.1 laws, regulations and guidelines for establishing a quality management system

Ø the People's Republic of China and Drug Administration Law and its implementing regulations

Ø Pharmaceutical Manufacturing Quality Management Standard (2010 Edition)

Ø Provisions on the Supervision and Administration of the Subject Responsibility of Drug Marketing Authorization Holders for Implementing Drug Quality and Safety

Ø Pharmacovigilance Quality Management Practice

Ø Guidelines for the International Technical Coordination Committee for the Registration of Medicines (ICH) Q10

Ø Guidelines for Drug Inspection Cooperation Program (PIC/S)

Food and Drug Administration (FDA)CGMP (Current Good Manufacturing Practices)

Ø EU and WHO GMP (Good Manufacturing Practice)

Ø ISO 9001: Quality Management System Requirements

4.2 define the quality objectives of the enterprise, such as ensuring that the products meet the requirements of national laws and regulations and relevant quality standards, and meeting customer needs.

Ø Express the company's commitment to quality, such as providing high-quality, safe and effective pharmaceutical products through continuous improvement and improvement of the quality management system.

Ø Explain the quality principles of the enterprise, such as following national regulations and quality management norms, improving work efficiency and product quality, and improving customer satisfaction, etc.

5. File Structure

Ø Describe the preparation, review, approval and revision procedures of the quality manual to ensure the applicability, validity and accuracy of the manual.

Ø To define the requirements for the issuance, use and storage of the manual and ensure that all relevant personnel have access to and use the manual. Emphasize the confidentiality of the manual, and do not provide the manual to personnel outside the company without approval.

5.1 Basic requirements 5.3 quality standards and procedures Control 5.4 of 5.2 documents and records Inspection records and reports

6. Process and product quality

6.1 R & D and technology transfer 6.6 customer satisfaction (complaint, delivery, recall) 6.2 commercial production 6.7 product acceptance/non-conformance 6.3 quality audit results (internal and external) 6.8 product annual review 6.4 official inspection 6.9 system quality review and analysis 6.5 pharmacovigilance monitoring 6.10 product delisting

7. Management Responsibilities

7.1 management commitment 7.4 quality plan 7.2 quality policy 7.5 management review 7.3 quality objective 7.6 internal communication

8. Resource Management

Provision of 8.1 resources

Provision of 8.1 resources 8.3 infrastructure

Ø Workshop

Ø Utilities

Ø Inspection instrument

Ø Production Equipment

Ø Basic requirements for IT infrastructure 8.2 personnel

Ø Job Responsibilities

Training and assessment of 8.3 procurement materials management 8.5 product ownership change management.

9. Quality Management System Elements

9.1 product quality monitoring system 9.5 product production cycle management 9.2 corrective and preventive measures system 9.6 quality management system life cycle management 9.3 change management system 9.7 sample retention and stability 9.4 quality risk 9.8 non-conforming products and scrap.

10. APPENDIX AND RELATED DOCUMENTS

10.1 Appointment Letter and Authorized Filing 10.3 Product and Process Catalog 10.2 Quality Management Relevant Standards and Procedure Documents Catalog 10.4 Organization Chart of Company and Department

Durst (DST) is constantly concerned about the dynamics of the industry and is committed to a deep understanding of the real needs of pharmaceutical companies. In order to better serve the majority of pharmaceutical companies, we will continue to launch relevant articles, share industry cutting-edge information, interpret policies and regulations, discuss technology trends, customized services, and share successful cases and practical experience.

As a professional service organization in the pharmaceutical industry, DST will continue to give full play to its advantages, pay attention to the needs and dynamics of pharmaceutical enterprises, and provide them with valuable information and services. We look forward to working with the majority of pharmaceutical companies to jointly promote the healthy development of the industry.