Drug GMP certification application materials require refinement of Shanghai Sujing

1. The overall situation of the company

1.1 Corporate Information

â—†Enterprise name, registered address;

â—†Enterprise production address, zip code;

â—† Contact, fax, contact number (including 24-hour contact for emergency public health emergency, contact number).

1.2 What is the pharmaceutical production situation of the enterprise?

â—† Briefly describe the production activities approved by the (food) drug regulatory authority, including import packaging, export, and drug information obtained from foreign licenses;

? Description of the scope of production of drugs?

â—† Business license, drug production license, and copy of relevant certification documents issued by overseas institutions that involve export;

1 A copy of the production license should be provided at the same time; 2 If there is entrusted (trusted) production, the corresponding approval document should be provided at the same time.

â—†All varieties that have obtained the approval number (can be divided into different addresses of the factory to fill out, and indicate whether it is produced all the year round, the output list of the past three years as an attachment);

1 variety table (serial number, product name, specification (packing specification), approval number, implementation standard, production workshop (factory area), whether it is produced all the year round) (Schedule 1)

2 List of production in the past three years (serial number, product name, specification, batch, annual output) (Schedule 2)

â—† Whether the production address has the operation of dealing with highly active and highly sensitizing materials such as highly toxic and sex hormone drugs, if any, should be listed in the attachment.

1 If there is no such item, it should be stated here that “there is no such operation”. 2 If such operations are carried out, they should be clearly stated in the plant facilities.

1.3 What is the scope of this drug GMP certification application?

â—† List the production line of the drug GMP certification, copy of the production dosage form, variety and registration approval documents of related products;

1 Clearly indicate the workshop or production line of this certification? The list shows the certified varieties (serial number, product name, specification, dosage form, batch) (Schedule 3)

2Applicable for the registration of certified varieties and copies of quality standards

â—† The latest inspection of the production line by the (food) drug regulatory authority (including the date of inspection, inspection results, defects and rectification, and the relevant drug GMP certificate). If the production line passes the inspection of the drug GMP outside the country, it will provide its inspection.

1 A copy of the defect item and the rectification report was last checked;

2 A copy of the GMP certificate for the relevant certification workshop.

3 If there is an overseas inspection, provide a copy and instructions.

1.4 Major changes since the last GMP certification of drugs

â—† Briefly describe the changes in key personnel, equipment, and varieties after the last certification inspection.

1 key personnel, facilities and equipment, products (such as workshops to increase or decrease new varieties)

Content should include changes, time, drug approval or filing status

2 If there is no change, it should be clearly stated that there is no change.

3 file changes do not have to be described here

2. Enterprise quality management system

2.1 Description of the enterprise quality management system

â—† The relevant management responsibilities of the quality management system include the duties of senior management, production management person in charge, quality management person in charge, quality attorney and quality assurance department;

â—† Briefly describe the elements of the quality management system, such as the organization, main procedures, processes, etc.

Four key personnel and responsibilities of the Quality Assurance Department.

It is recommended to briefly describe the implementation of the actual management system of the enterprise with reference to the ten requirements of Article 9 of the GMP “Drug Quality Assurance System”.

2.2 Finished product release procedure

â—† The overall description of the release procedure and the basic conditions (qualifications, etc.) of the release personnel.

1 release process description (flow chart) - batch production record review, batch inspection record review, review, approval, certificate issuance.

2 The specific personnel responsible for product release, whether or not to transfer authorization.

3 Qualifications of the attorney and transferee (name, age, graduate school, major, graduation time, relevant work experience and years). (Schedule 4)

2.3 Supplier Management and Entrusted Production and Entrusted Inspection

â—† Outline the requirements for supplier management and the quality risk management methods used in the assessment and assessment;

1 supplier rating

2 Supplier Quality Assessment

3 new suppliers adopt basic quality requirements

4 Supplier Change Management

5 material (supplier) quality review

6 supplier list

â—† Briefly describe the situation of commissioned production; (if any)

Entrusted production varieties and organization and management, especially the quality control, product release and quality review of commissioned production.

â—† Briefly describe the circumstances of the entrusted inspection. (if any)

1 If there are entrusted inspections, including original auxiliary materials and entrusted inspection of packaging materials, there should be a list of entrusted inspection items, and explain their management and filing status.

2 If there is no commissioned production or commissioned inspection, it should clearly state “no entrusted production, entrusted inspection”

2.4 Enterprise Quality Risk Management Measures

â—† Briefly describe the company's quality risk management policy;

â—† The scope and focus of quality risk management activities and the process of risk identification, evaluation, control, communication and audit under the quality risk management system.

1 Is there a risk management program and what is the risk management policy?

2 How to determine the scope of application of risk management, what is the focus, and when to implement risk assessment measures.

3 What are the ways of risk assessment?

â—† The company conducts annual product quality review and analysis and the focus of the investigation.

1 Product quality review management method (flow chart), responsibilities.

2 The focus (scope) and implementation of the quality review.

3 Association with trend analysis (if any).

3. Personnel

3.1 Organizational chart (including top management) including quality assurance, production and quality control, and the organization chart of the quality assurance, production and quality control departments;

1 corporate organization chart

2 Production and quality department organization chart and main responsibility description (should include all the departments involved in quality management elements)

3.2 The number and qualifications of key personnel of the company and the main technical personnel engaged in quality assurance, production and quality control;

1 At least 4 key personnel forms (name, gender, age, position, graduate school, major, relevant working years) (Schedule 5)

2 Production, quality control, quality assurance technical personnel and qualifications (name, gender, age, position, graduate school, major, working years) (Schedule 6)

3.3 Number of employees in various departments such as quality assurance, production, quality control, storage and shipping.

1 employee roster. (Schedule 7)

2 Departmental breakdown should be consistent with the organizational chart.

4. Plants, facilities and equipment

4.1 Plant

◆ Briefly describe the time and type of construction and use of the building (including the structure and the material of the inner and outer surfaces), and the area of ​​the site;

Should include description of plant facilities and production workshops

â—† The general layout of the plant area, the layout of the production area and the flow chart, indicating the proportion. The cleanliness level of the room, the pressure difference between adjacent rooms, and the production activities carried out by the room should be indicated;

â—† Briefly describe the layout of all production lines in the scope of application for certification;

The corresponding relationship between the application for the certified dosage form (product) and the workshop should be specified when there are multiple workshops of the same variety.

â—† Brief description of warehouse, storage area and special storage conditions.

Description of the general situation of the storage area? Distribution area, storage area division, sampling area layout, special storage conditions (shady, low temperature, cold storage, etc.)

4.1.1 Brief description of the air conditioning purification system

â—†The working principle, design standard and operation status of air conditioning purification system, such as air inlet, temperature, humidity, pressure difference, air exchange frequency, return air utilization rate, etc.

1 system description

2HVAC system number, corresponding model, control area (picture) area, clean level

3 partial laminar flow description

4 system control chart

5 confirmation and verification status description

6 operation and maintenance situation description

4.1.2 Brief description of the water system

â—†The working principle, design standard, operation status and schematic diagram of the water system.

1 system description (water source, water production capacity, preparation process and main parameters, distribution system material)

2 water system control chart

3 distribution system diagram

4 confirmation and verification status description

5 Description of operation and maintenance (circulation mode, cleaning and disinfection, monitoring)

4.1.3 Brief description of other utilities

â—† Other utilities such as compressed air, nitrogen, etc., working standards, design standards and operating conditions.

1 system description (source, production capacity, preparation process and main parameters, distribution system material)

2 system control distribution map

3 confirmation and verification status description

4 operation and maintenance situation description

4.2

4.2.1 List the main instruments and equipment used for production and inspection.

1 main production equipment list

Workshop (production line)

Serial number, name, manufacturer, specification model, production capacity, installation location, confirmation and verification time, verification cycle (Schedule 8)

2 main inspection equipment list

Laboratory (if there are multiple laboratories)

Serial number, name, instrument number, manufacturer, specification model, accuracy, calibration time, calibration period, calibration unit, setting position (Schedule 9)

4.2.2 Cleaning and disinfection

â—† Briefly describe the methods and verification of cleaning, disinfection and direct use of drugs on the surface of equipment.

1 production plant cleaning management

2 Clean and disinfection management of clean room in production workshop

3 main production equipment cleaning cleaning and disinfection (sterilization) management (method, cycle, verification)

4.2.3 Critical computerized systems related to the quality of pharmaceutical production

â—† Briefly describe the design and use verification of key computerized systems related to the quality of pharmaceutical production.

It should be stated whether there is a computerized management system (such as material management system, weighing system, production control system, etc.)

Main system design, usage description (system control chart)

Main system verification description

5. Documentation

â—† Describe the enterprise's file system;

â—† Briefly describe the drafting, revision, approval, issuance, control, and archiving systems for documents.

1 file system structure level description

2 file classification description, file structure diagram

3 file management status description

6. Production

6.1 Production of products

â—† Summary of the products produced (brief);

Correspondence between product and production workshop (line), product history, batch, production, product control (key quality attributes, production control methods), etc.

â—† The process flow chart for applying for the certified dosage form and variety, and indicating the main quality control points and projects.

Flow chart

Quality Control Project Table (Process, Control Project, Indicator, Frequency) (Schedule 10)

6.2 Process verification

â—† Briefly describe the principles and overall situation of process validation;

1 Process verification management point description (verification method, organization department, process, cycle, re-verification, change verification, etc.) (Schedule 11)

2 Certification product process verification registration form. (name, specification, workshop, verification time) (schedule 12)

â—† Briefly describe the principles of rework and rework.

1 If there should be written management principles, methods

2 If there is no clear indication that the company has no rework and rework

6.3 Material Management and Warehousing

â—† Handling of raw materials, packaging materials, semi-finished products and finished products, such as sampling, inspection, release and storage;

â—† Disposal of unqualified materials and products.

1 Storage material management (acceptance, storage, inspection, sampling, qualification, issuance, return)

2 Management of intermediate materials (receiving, turnover), semi-finished products (storage conditions, cycle, issuance, etc.)

3 finished product management (waiting for storage location, storage time, issue)

4 Management of non-conforming products (discovery, report, approval, temporary storage, processing, deviation management, etc.)

7. Quality control

â—† Describe all activities carried out by the enterprise quality control laboratory, including inspection standards, methods, verification, etc.

1 Quality management organization (institutional division and responsibilities, workflow, etc.)

2 quality inspection site layout layout

3 quality standards development approval management

4 verification and verification of verification methods

5 continuous stability experiment management situation

8 Shipping, Complaints and Recalls

8.1 Shipping

â—† Briefly describe the controls required for the product during transportation, such as temperature/humidity control;

â—† A method to ensure product traceability.

8.2 Complaints and recalls

â—† Briefly describe the procedures for handling complaints and recalls.

9 self-test

â—† Briefly describe the self-checking system, focusing on the regional selection criteria in the planned inspection, the implementation of the self-inspection and the rectification.

Correction of defects in drug GMP inspection

Drug GMP certification (tracking, flight) inspection defect correction report

Compare the new GMP rectification table

Company Name: (seal)

No. Defects Content Correction Measures Responsible Person/Department Completion Time Remarks

report time:

Note: 1. The attached table 1-12 in the detailed rules mainly refers to the content suggestion that the enterprise can express it in the form of a schedule. Due to the actual situation of each enterprise, the contents of individual forms may be slightly different, and the enterprise may formulate according to its own actual conditions. form.

2. In accordance with the requirements of the “Notice of the State Administration of Food and Drug Administration on the investigation and analysis of the production capacity of enterprises that have passed the newly revised drug GMP certification” (Food and Drug Administration Safety Letter [2013] No. 8) For the investigation and analysis of the production capacity of pharmaceutical GMP-certified enterprises, since January 22, 2013, all enterprises that have submitted new GMP certification applications for pharmaceuticals should report a change in production capacity before and after the new revised drug GMP certification. Situation sheet

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