Summary of the new version of GMP certification

Checkpoint 1: Organizational chart (Organizational charts come from documents, not just a red header, everything must be supported by documents).

Checkpoint 2: Whether the quality department is set up independently, whether it participates in all quality activities and reviewing GMP documents;

Checkpoint 3: Whether the responsibilities of key personnel are clear and complete, and the recruitment should be supported by documents. Such as: qualifications, experience, skills, etc. must be stipulated in documents;

Checkpoint 4: Whether the relationship between the person in charge of the enterprise and the actual person in charge is authorized;

Checkpoint 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 that the personnel training is not in place, the personnel may have the phenomenon that the training is not in place, but there can be no problems with the whole set of documents related to the training;

Checkpoint 6: Changing procedures for sanitation personnel, health examination, management of visitors, whether work clothes and work shoes are numbered, and the cleaning of clothes should be recorded (stipulations made after risk assessment).

Plant and Facilities

Checkpoint 1: Plant, utilities, fixtures. (drawing)

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

Checkpoint 3: Cleaning and maintenance procedures for plant facilities;

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

Checkpoint 6: Anti-insect and anti-rodent hardware measures and management documents and records;

Checkpoint 7: Personnel access to production, storage, and quality control areas. (Control irrelevant personnel to enter and exit at will)

Checkpoint 8: Logistics route (from warehouse to workshop, pay special attention to management measures during transportation).

Production area

Checkpoint 1: Flow chart of production process, layout of supply air, return air and exhaust air in clean area (requirements such as purification level and temperature, humidity and pressure difference are determined according to the risk assessment of the drug production process)

Checkpoint 2: Environmental Testing Report

Checkpoint 3: Design of dust-generating operation room, raw and auxiliary material weighing room, measures to prevent contamination and cross-contamination

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

storage area

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

Checkpoint 2: Setting of material receiving, issuing and shipping areas;

Checkpoint 3: Whether unqualified materials and recalled drugs are stored in isolation (physical isolation of separate unqualified warehouses or stainless steel construction of fences, pull lines or divided areas is not acceptable);

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

Checkpoint 5: How to request for inspection and sampling of incoming materials (specialists on sampling vehicles have opinions, if the enterprise has the conditions, it can be used as a sampling room).

laboratory

Checkpoint 1: The layout of the microbiology room, the laboratory and the production area are separated;

Checkpoint 2: Sample reception and disposal, storage area;

Checkpoint 3: Whether the instrument has a special instrument room;

Checkpoint 4: Chemical reagent storage area.

equipment

Checkpoint 1: Equipment list;

Checkpoint 2: Records and documents of equipment procurement, installation, confirmation, and scrapping;

Checkpoint 3.: Risk assessment of key equipment adversely affecting drug quality (equipment with risk of breakage and falling off, such as: shaker granulator, broken screen of shaker screen);

Check point 4.: Whether the lubricant and coolant management regulations of the equipment meet the requirements;

Checkpoint 5: Management procedures and related records for the procurement, acceptance, storage, maintenance, use, distribution and scrapping of equipment molds;

Checkpoint 6: Whether the modified or overhauled equipment has a change record, whether the equipment is confirmed after the overhaul, and whether it is used for production after confirming that it meets the requirements;

Checkpoint 7: Records of equipment and facility cleaning operation procedures, whether the cleaning effect has been risk assessed, and whether it has been confirmed;

Check point 8: Whether there is a record of equipment use and maintenance, and whether the record can reflect all the contents to be checked as stipulated in the document;

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

Checkpoint 10: Whether weighing instruments, measuring tools and meters are calibrated

Pharmaceutical water

Checkpoint 1: Unit related files (including design and installation drawings);

Check point 2: Process water flow diagram (total return to storage tank, each water point) with or without dead pipes;

Checkpoint 3: Process water conductivity and control indicators;

Checkpoint 4: Water quality monitoring regulations and related records for raw water and pharmaceutical water;

Checkpoint 5: Cleaning, disinfection, maintenance procedures and related records of purified water pipelines;

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

Checkpoint 7: Validation of purified water systems.

Air Conditioning System

Checkpoint 1: Unit related files (including design and installation drawings);

Check point 2: Air-conditioning system diagram (air supply diagram, return air diagram, straight row diagram);

Checkpoint 3: Daily monitoring of the air-conditioning system (on-site inquiry);

Checkpoint 4: Air-conditioning system monitoring regulations and related records;

Checkpoint 5: Cleaning, disinfection, maintenance procedures and related records of the air-conditioning system;

Checkpoint 6: Risk assessment of the air-conditioning system (deviations and changes);

Checkpoint 7: Validation of the air conditioning system.

materials

Checkpoint 1: Quality standards for raw and auxiliary materials;

Check point 2: Printing ink (with or without, if any, whether it is above food grade);

Checkpoint 3: Operating procedures and records for the receipt, storage, distribution, use and delivery of materials;

Check point 4: material sampling (sampling certificate) inspection report, release note;

Checkpoint 5: Approval documents related to imported medicinal materials;

Checkpoint 6: Outer packaging logo (design in strict accordance with the terms, such as: Chinese medicine decoction piece logo, intermediate logo, re-inspection period and validity period, storage conditions must be designed on the logo card);

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

Check point 8: How to store materials with special requirements (Chinese herbal medicine pieces that are easy to be mixed with flavor, Chinese medicine pieces that are stored in a cool and dry place, and alcohol for storage of flammable and explosive materials);

Checkpoint 9: Whether the warehouse layout is reasonable and whether anti-mosquito measures are in place, and the storage area must have a layout diagram;

Checkpoint 10: Complete and accurate identification is the foundation, and the consistency of the account card is the core (starting from vertical and horizontal inspection).

Supplier Audit and Evaluation Warehouse Area

Checkpoint 1: Supplier audit and evaluation management procedures;

Checkpoint 2: List of qualified suppliers;

Checkpoint 3: Supplier audit and hierarchical management (whether there is a risk assessment for the classification);

Checkpoint 4: Authorization of manufacturers and distributors (with relevant authorization) Both manufacturers and distributors must have licenses, and major material suppliers should be audited on site;

Checkpoint 5: Audit records and audit reports (should elaborate on the company profile and quality management capabilities);

Checkpoint 6: Quality Assurance Agreement (please refer to the clauses for whether the responsibility is clear)

Recycle

Checkpoint 1: Recycling operation procedures and records (quantity recycled, processing procedures);

Checkpoint 2: Is the definition of recycling understood correctly

Management of reworked products

Checkpoint 1: Rework product management procedures;

Checkpoint 2: Is the rework product approval complete?

Checkpoint 3: Reworked product production records;

Checkpoint 4: Risk assessment, stability inspection;

Checkpoint 5: Is the definition of rework understood correctly

Confirmation and Verification

Checkpoint 1: Validate the master plan;

Checkpoint 2: The scope and extent of validation and verification should be determined through a risk assessment;

Checkpoint 3: Confirmation of changes in factory buildings, facilities, equipment, and inspection instruments, and maintain a continuous verification state;

Checkpoint 4: Equipment Cleaning Validation Protocol Report;

Checkpoint 5: Verification of disinfection or sterilization of critical equipment;

Checkpoint 6: Three batches of production process validation.

Production management

Check point 1: production license, production approval, production process, quality standard;

Checkpoint 2: batch production instructions, batch packaging instructions, batch production records, batch packaging records;

Checkpoint 3: Whether the key process parameters and production prescription are consistent with the approval document;

Checkpoint 4: Consistency of process specification and SOP, matching of production equipment and process;

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

Checkpoint 6: Control measures to prevent confusion, contamination and errors, handling of deviations;

Checkpoint 7: Control of special product dust (dust removal facilities and on-site effects);

Checkpoint 8: site clearance, personnel control, environmental control, tool management, equipment log;

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

Checkpoint 10: Can the overall layout and staffing meet production requirements

Quality Control Laboratory

Checkpoint 1: Whether the personnel meet the requirements;

Checkpoint 2: How to determine the authorization of the sampling personnel (whether there is an authorization letter);

Check point 3: Whether the instruments and equipment can meet the variety inspection requirements and whether they are calibrated. View instrument use, maintenance, cleaning management procedures and records;

Checkpoint 4: List of instruments and equipment, check whether the inspection quantity calculation equipment can meet the needs;

Checkpoint 5: Management procedures for standards and reference substances, sources of standards and reference substances and records of receipt;

Checkpoint 6: Whether the quality standards are complete and controlled (e.g. Chinese Pharmacopoeia);

Checkpoint 7: Check whether operating procedures and SOP related records are formulated;

Checkpoint 8: Inspection method validation management procedures, reports and records;

Checkpoint 9: Check the suitability of gas phase, infrared and other systems (verification or confirmation of report records) on the management of maps and data;

Checkpoint 10: Sampling management, how to store, distribute, and use samples (with records), and how to control blank records for inspection;

Checkpoint 11: How to manage the inspection data results exceeding the standard, and whether there is an SOP;

Checkpoint 12: Management procedures for retained samples, stability inspection status (annual plan, inspection plan, inspection batch and inspection cycle, stability inspection after major changes or deviations) whether the actual retained samples conform to the regulations;

Checkpoint 13: How to manage highly toxic and special reagents (see site, documents and records);

Checkpoint 14: Culture medium suitability test (the inspection record should reflect the batch number of the culture medium);

Checkpoint 15: Whether the organic solvent residue limit in the extraction process of traditional Chinese medicine is specified in the quality standard.

change management

Checkpoint 1: Whether the change control management procedures specify principles, classifications, and procedures (changes involve scope, control procedures, management departments and personnel; relevant documents and records);

Checkpoint 2: Post-change evaluation management and inspection and evaluation records;

Checkpoint 3: Evaluation, review and approval of rework, rework, impact on validation and stability;

Checkpoint 4: OOS investigation control system.

Deviation handling

Checkpoint 1: Deviation handling management procedures, SOP;

Checkpoint 2: Records of investigation, reporting, processing, correction, etc. related to deviation handling (Deviation and failure inspection related to production and testing: recording, evaluation, timely investigation, including corrective actions taken).

Corrective Action

Checkpoint 1: Initiation of corrective action;

Checkpoint 2: Corrective action versus deviation;

Checkpoint 3: Corrective Action and Preventive Action Risk Assessment

Product Quality Review

Checkpoint 1: Product quality review and analysis management procedures and SOPs;

Checkpoint 2: Product review: at least once a year, including evaluation report (retrospective analysis, quality trend analysis graph)

Complaints and Adverse Reactions

Checkpoint 1: ADR reporting and monitoring system;

Checkpoint 2: Complaint management procedures and SOPs, complaint records;

Checkpoint 3: Evaluation, investigation, processing records;

Checkpoint 4: Complaints are regularly evaluated and analysed.

commissioned production

Check point 1: Whether the content of the contract 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, record situation;

Checkpoint 3: Evaluation of the quality management system of the entrusted party, and management regulations for the transportation and storage of intermediates.

Commissioned inspection

Checkpoint 1: Entrusted inspection contract (whether the responsibility lies with the entrusting party);

Checkpoint 2: Commissioned inspection of management documents and sops;

Checkpoint 3: The content of the approval document entrusted by the provincial bureau;

Checkpoint 4: The client's assessment records and reports of the client, and the client's supervision record of the client's inspection process;

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

Product Shipments and Recalls

Checkpoint 1: Product delivery management procedures;

Checkpoint 2: Sales records (name, batch number, quantity, delivery address, contact information);

Checkpoint 3: Specific measures to prevent damage and contamination by means of transportation (cold chain);

Checkpoint 4: Recall management procedures (whether the recall is reported to the drug regulatory authority, storage, disposal and evaluation of the recalled product);

Checkpoint 5: Recall records;

Checkpoint 6: Mock recall (emergency drill).