Check point 1: Organization chart (organization chart from the document, not just the next red text, everything must have document support).

Check point 2: whether the quality department is set up independently, whether it participates in all quality activities and audits GMP documents;

Check point 3: The responsibilities of key personnel are clear and complete, and the recruitment should be supported by documentation. Such as: qualifications, experience, skills and other aspects should be documented;

Check point 4: the relationship between the person in charge of the enterprise and the actual person in charge, whether there is authorization;

Inspection point 5: Responsibilities of the training management department, annual training plan, training plan, training program, relevant records, training assessment, training tracking, etc. Every enterprise has the situation of personnel training is not in place, personnel can have the phenomenon of training is not in place, but the set of documents related to training can not have problems;

Inspection point 6: changing procedures of health personnel, health examination, management of visitors, whether the shoes of the workers are numbered, and the cleaning of the clothes should be recorded (the provisions made after the risk assessment).

Plant and facilities

Inspection point 1: plant, utility facilities, fixed. (Drawing)

Inspection point 2: layout diagram of production area, storage area and quality control area;

Inspection point 3: plant facilities cleaning and maintenance procedures;

Check point 5: Temperature and humidity control (warehouse temperature and humidity need to be verified)

Inspection point 6: pest and rodent prevention hardware measures and management documents and records;

Check point 7: personnel access to production, storage, and quality control areas. (Control random access of irrelevant personnel)

Check point 8: Logistics route (from warehouse to workshop, paying special attention to management measures during transportation).

Production area

Inspection point 1: production process flow chart, clean area air supply, return air, exhaust air layout diagram (according to the risk assessment of the drug production process to determine the purification level and temperature, humidity and pressure difference requirements)

Check point 2: Environmental test report

Inspection point 3: Dust production operation room, raw materials weighing room design, prevention of pollution and cross-contamination measures

Check point 4: Whether the storage function room can meet the temporary storage and circulation of materials in the workshop.

Warehouse district

Check point 1: warehouse layout diagram (how to store materials with special storage requirements) area division is reasonable;

Check point 2: the setting of the receiving, distributing and shipping area of materials;

Inspection point 3: Whether unqualified materials and recalled drugs are stored in isolation (it is not acceptable to build a separate unqualified warehouse for physical isolation or build a fence, pull wire or partition area with stainless steel);

Check point 4: Whether the material storage can meet the material storage conditions;

Inspection point 5: how to check the incoming materials, how to sample (sampling car experts have opinions, such as enterprises can do sampling room).

laboratory

Inspection point 1: microbial room layout, laboratory and production area are separated;

Inspection point 2: sample reception, disposal, storage area;

Check point 3: Whether the instrument has a special instrument room;

Check point 4: Chemical reagent storage area.

equipment

Check point 1: equipment list;

Inspection point 2: equipment procurement, installation, confirmation, scrap records and documents;

Inspection point 3. Risk assessment of adverse effects of key equipment on drug quality (equipment with risk of breakage and falling off, such as: swing granulator, concussion screen breakage);

4. Check whether the lubricant and coolant management regulations of the equipment meet the requirements;

Inspection point 5: equipment mold procurement, acceptance, storage, maintenance, use, release and scrap management procedures and related records;

Check point 6: whether there is a change record of the equipment after renovation or overhaul, whether the equipment is confirmed after overhaul, and whether it is used for production after confirming that it meets the requirements;

Check point 7: equipment, facilities cleaning operation procedures record, cleaning effect is through risk assessment, whether it is confirmed;

Check point 8: Whether there are records of equipment use and maintenance, and whether the records can reflect all the contents to be checked according to the documents;

Check point 9: equipment status identification, equipment confirmation parameters range;

Check point 10: Whether the weighing instrument, measuring tool and instrument are verified

Pharmaceutical water

Inspection point 1: unit related files (including design and installation drawings);

Check point 2: there are no blind pipes in the process water flow diagram (total delivery total return to the storage tank, each water point);

Inspection point 3: electrical conductivity of process water and control index;

Inspection point 4: raw water, pharmaceutical water quality monitoring regulations and related records;

Inspection point 5: cleaning, disinfection, maintenance procedures and related records of purified water pipelines;

Check point 6: Risk assessment of purified water systems (deviations and changes);

Check point 7: Validation of the purified water system.

Air conditioning system

Inspection point 1: unit related files (including design and installation drawings);

Check point 2: air conditioning system diagram (supply air diagram, return air diagram, in-line diagram);

Inspection point 3: Daily monitoring of air conditioning system (on-site inquiry);

Inspection point 4: air conditioning system monitoring regulations and related records;

Inspection point 5: air conditioning system cleaning, disinfection, maintenance procedures and related records;

Check point 6: Risk assessment of air conditioning system (deviation and alteration);

Check point 7: Verification of the air conditioning system.

materiel

Inspection point 1: quality standard of raw materials;

Check point 2: printing ink (yes, no, if any, whether it reaches food grade or above);

Inspection point 3: Operation procedures and records of receiving, storing, distributing, using and shipping materials;

Inspection point 4: sampling of materials (sampling certificate) inspection report, release form;

Inspection point 5: relevant approval documents of imported medicinal materials;

Inspection point 6: Outer packaging identification (designed in strict accordance with the terms, such as: Chinese medicine decoction piece identification, intermediate identification, retest period and expiration date, storage conditions must be designed on the identification card);

Check point 7: Whether the material storage is reasonable (on-site inspection) how to manage the products to be inspected, unqualified products, qualified products (unqualified products and recalled materials must be physically isolated);

Check point 8: how to store materials with special requirements (easily flavored Chinese medicine pieces, cool stored Chinese medicine pieces, flammable and explosive materials storage alcohol);

Check point 9: whether the warehouse layout is reasonable and mosquito prevention measures are in place, and the storage area should have a layout map;

Inspection point 10: Complete and accurate identification is the foundation, and the account card is consistent with the core (vertical and horizontal inspection).

Supplier audit and evaluation of warehouse area

Inspection point 1: Supplier audit and evaluation management procedures;

Inspection point 2: List of qualified suppliers;

Inspection point 3: Supplier audit and classification management (whether the classification has a risk assessment);

Inspection point 4: The authorization of the manufacturer and the dealer (there is relevant authorization) The license of the manufacturer and the dealer should be available, and the main material supplier should be audited on site;

Inspection point 5: audit records and audit reports (should elaborate on the company's profile and quality management capabilities);

Check point 6: Quality assurance agreement (whether the responsibility is clear see the terms)

recycle

Inspection point 1: recycling operation procedures and records (recycling quantity, processing process);

Check point 2: The definition of recycling is understood correctly

Management of reworked products

Inspection point 1: rework product management procedures;

Check point 2: Whether the rework product approval is complete;

Inspection point 3: production records of reworked products;

Inspection point 4: risk assessment, stability inspection;

Check point 5: The definition of rework is understood correctly

Confirmation and verification

Check point 1: Verify the master plan;

Inspection point 2: The scope and extent of validation and verification should be determined by risk assessment;

Inspection point 3: Confirm the change of plant, facilities, equipment and inspection instruments, and maintain a continuous verification state;

Inspection point 4: equipment cleaning verification plan report;

Inspection point 5: Verification of disinfection or sterilization of key equipment;

Check point 6: three batches of production process verification.

Production management

Inspection point 1: production license, production approval, production process, quality standards;

Inspection point 2: batch production instructions, batch packaging instructions, batch production records, batch packaging records;

Check point 3: Whether the key process parameters and production prescriptions are consistent with the approval documents;

Check point 4: consistency of process rules and SOP, matching of production equipment and process;

Check point 5: actual operation ability, parameter control ability, material balance;

Inspection point 6: Control measures to prevent confusion, pollution and error, deviation treatment;

Check point 7: Control of dust of special products (dust removal facilities and on-site effects);

Inspection point 8: clearance situation, personnel control, environmental control, tool management, equipment log;

Inspection point 9: Changes in materials and equipment that affect product quality should be confirmed or verified;

Check point 10: the overall layout and personnel can meet the production requirements

Quality control laboratory

Check point 1: whether the personnel meet the requirements;

Check point 2: how to determine the authorization of sampling personnel (whether there is an authorization letter);

Check point 3: Whether the instrument and equipment can meet the needs of variety inspection, whether to check. Check instrument maintenance, cleaning management procedures and records;

Check point 4: list of instruments and equipment, check whether the inspection quantity calculation equipment can meet the demand;

Inspection point 5: management procedures of standard and reference products, sources of standard and reference products and receiving records;

Check point 6: whether the quality standards are complete and controlled (e.g., Chinese Pharmacopoeia);

Check point 7: check whether the operating procedures and SOP related records are developed;

Inspection key 8: Inspection method verification management procedures, reports and records;

Check point 9: gas phase, infrared and other system adaptability check (verify or confirm report records) map and data management;

Inspection point 10: sampling management, sample storage, distribution, use (to have records), how to control the blank records used in the inspection;

Inspection point 11: how to manage the test data results exceeding the standard, whether there is SOP;

Inspection point 12: the management procedures of retained samples and the stability inspection situation (annual plan, inspection program, inspection batch and inspection cycle, stability inspection after major changes or deviations) are consistent with the actual retained samples;

Inspection point 13: how to manage highly toxic and special required reagents (see the site, documents and records);

Check point 14: medium suitability test (test record should be able to reflect the batch number of medium);

Check point 15: Whether the residual limit of organic solvents in the extraction process of traditional Chinese medicine is specified in the quality standard.

Change management

Check point 1: Whether the change control management procedure specifies the principles, classifications and procedures (the scope of the change, the control process, the management department and personnel; Relevant documents and records);

Inspection point 2: Evaluation management and review evaluation records after the change;

Check point 3: Evaluation, review and approval of rework and reprocessing, impact on validation and stability;

Inspection point 4: OOS investigation control system.

Deviation treatment

Inspection point 1: deviation handling management procedures, SOP;

Inspection point 2: Investigation, reporting, treatment, correction and other records related to deviation processing (deviation and failure inspection related to production and testing: recording, evaluation, timely investigation, including corrective action taken).

Corrective action

Inspection point 1: the initiation of corrective action;

Check point 2: the relationship between corrective action and deviation;

Inspection point 3: Corrective action and preventive action risk assessment

Product quality review

Inspection point 1: product quality review and analysis management procedures and SOP;

Inspection point 2: Product review: at least once a year, including the evaluation report (retrospective analysis, quality trend analysis chart)

Complaints and adverse reactions

Inspection point 1: Adverse drug reaction reporting and monitoring system;

Inspection point 2: Complaint management procedures and SOP, complaint records;

Inspection point 3: evaluation, investigation, processing records;

Check point 4: Complaints are regularly evaluated and analyzed.

Commissioned production

Check point 1: Whether the contract content is complete and whether the quality responsibility is clear. Whether it has been approved by the provincial bureau;

Check point 2: material management, production management, records;

Inspection point 3: The evaluation of the quality management system of the trustee, the management regulations of the transportation and storage of intermediates.

Commissioned inspection

Inspection point 1: entrusted inspection contract (whether the responsibility lies with the principal);

Inspection point 2: entrusted inspection management documents and sop;

Inspection point 3: the content of the approval document entrusted by the provincial bureau;

Inspection point 4: the principal's evaluation records and reports of the agent, and the principal's supervision records of the agent's inspection process;

Inspection point 5: Commissioned inspection report (original with red seal).

Product shipping and recall

Inspection point 1: product shipping management procedures;

Check point 2: sales records (name, batch number, quantity, delivery address, contact information);

Inspection point 3: Transport mode (cold chain) specific measures to prevent damage pollution;

Inspection point 4: recall management procedures (whether the recall is reported to the drug regulatory department, storage, disposal and evaluation of recalled products);

Check point 5: recall records;

Check point 6: Mock recall (emergency drill).