Implementation responsibility

Gmp authentication needs to be established file task serial file name file content standard
1
Personnel file
1. Resume, diploma, title certificate;
2. The file of the appointment and dismissal of Zhonggan and above, the general authority authorized the deputy general manager of the quality of power of attorney
3. Key position external qualification certificate: laboratory technician, boiler worker, electrician, metering staff, Chinese medicine purchase and sales staff.
4. The person in charge of the quality of the company, the person in charge of the quality department, and the person in charge of the production department require relevant professional college or above and certain work experience. Other important positions include qa supervisor, workshop director, and Chinese medicine procurement.

2
Health file

1. Employee health card, health certificate of the county-level and above units over the years
2. Proof of abnormal treatment of physical examination results, certificate of medical examination for rehabilitation
3. Note: Including the entire production quality system, it is easy to miss the cleaners, temporary workers, machine repairs, chefs, etc.; the production quality system is checked at least once a year, and the other recommendations are biennial.

3
Training file

1. Implementation of annual training plan and training
2. Each training check-in form and training materials
3. Training blank test papers

4
Institutional responsibility

1. Company organization chart, quality management organization chart, organization of each department;
2. Functions and duties of the institutions at all levels;
3. The employee roster can be subdivided into a list of managers, a list of quality management personnel, and a list of technicians; the content includes number, position, name, gender, date of birth, education, graduate school, major, duration of medicine, title, Entry time, remarks.

5
File management file
1. Current file directory
2. All original files and a set of archived copies are stored separately and arranged according to the file code;
3. File release record, key file draft record
4. File change account and change record;
Obsolete, obsolete archives, destroyed records, obsolete, obsolete archives with obsolete, obsolete seals and stored separately from the original archives.

6
Printed file

1. Approval of the printing and packaging materials supervision department;
2. The qa signature review of the pre-printed color draft of the supplier;
3. Standard sample: The package material is distributed and recorded according to the file after being signed and stamped by qa. The old version is recycled and destroyed after the identification.
Qa production distribution: qa, qc, procurement, warehouse, one workshop, as a standard for procurement, acceptance, inspection, use

Signature of the gmp certification team leader: Signature of the responsible person:

Gmp certification implementation responsibility person Wang Liqi job deputy general department factory
Gmp authentication needs to be established file task serial file name file content standard
1
drawing
1. Try to obtain an electronic version of the drawings to facilitate the production of the application materials in the future.
2. Factory floor plan, plant layout, storage area layout, quality inspection laboratory layout).
3. Air conditioning purification system diagram
4. Purified water preparation system diagram, distribution system diagram, compressed air system diagram.

2
Material proof

1. Purified water storage tank, pipeline, valve, sampling valve, pump and other stainless steel proof, the material proof of the filter; first model network - learning library: diyifanwen.com

2. The stainless steel material certificate of the inner surface of the equipment, the storage tank and the liquid medicine conveying pipeline which are in direct contact with the medicine;
3. Proof of clean work clothes, clean area cleaning tools without falling off fibers, no static electricity

Signature of the gmp certification team leader: Signature of the responsible person:
Gmp certification implementation responsibility person Du Shufang position manager department quality assurance department
Gmp authentication needs to be established file task serial file name file content standard
1
Quality file

2
Finished product batch file
1. Inspection records and reports;
2. Batch production records, audit release records;
3. Other various inspection accounts and records.
4. Entrusted inspection of the drug regulatory bureau approval, entrusted inspection agreement, counterpart measurement certificate or gmp certificate

3
Sample stability file
1. Finished sample observation registration, inspection record, result summary table, observation summary;
2. Leave the sample account card and ask for the same card.

4
Environmental monitoring file

1. New factory environmental protection certificate, fire certificate
2. Test report of provincial and municipal pharmacies in clean areas
3. Annual report on the full inspection of epidemic prevention stations for drinking water points
4. Periodical monitoring records, reports, and accounts for drinking water enterprises
5. Purified water regularly monitors records, reports, ledgers, pipelines, tank cleaning and sterilization records, verification reports, etc.
6. Clean area enterprises' own monitoring procedures, regular monitoring records, reports, ledgers and monitoring instruments
7. Air purification system filter cleaning replacement record, verification report, etc.
8. Clean area cleaning and disinfection records, work clothes washing records

5

Quality inquiry, user complaints and adverse reaction processing records

Signature of the gmp certification team leader: Signature of the responsible person:
Gmp certification implementation responsibility person Gao Qian job general manager department factory
Gmp authentication needs to be established file task serial file name file content standard
1
Self-test file
1. Completion of self-inspection plan, self-inspection record, report, and corrective measures

Signature of the gmp certification team leader: Signature of the responsible person:

Gmp certification implementation responsibility person responsible Liu Jianguo deputy general department of marketing department
Gmp authentication needs to be established file task serial file name file content standard
1
Supplier profile

1. List of qualified suppliers;
2. Qualified suppliers' information shall be carried out according to the management procedures of the corresponding suppliers, paying attention to the validity period of the original and auxiliary materials standards and licenses, the internal packaging materials registration certificate, the import registration certificate and other documents and the fresh seal of the company.
3. Pay special attention to the business scope of the operating company, and cannot purchase materials that are out of scope. To purchase materials from operating companies, it is necessary to collect relevant purchase channel information and stamp the production enterprises or business enterprises.
4. Non-pharmacopoeia, excipients and inner packaging materials may not be fully inspected if the other party provides a full inspection report, and the supplier is required to provide a full inspection report, preferably in batches.

2
Customer file

1. Customer list
2. The customer's legal business license and the validity period
3. Sales records, note that the sales unit may not fill in individuals or units that are not qualified or out of scope.

3

Return processing account, record.