Objective: To establish a scientific and standardized material management system to facilitate material management.
Scope of application: This procedure is applicable to the material management of the company.
Person in charge: the personnel of the material control department are responsible for the implementation of this regulation.
Text content:
1 management of materials
1. 1 The material control department is responsible for the management of all materials of the company, including finished products, raw materials, nonconforming products, packaging materials, spare parts, glass instruments, chemical reagents and office supplies. The management of finished products, packaging materials, raw and auxiliary materials and unqualified products must strictly implement the relevant SOP and GMP.
1.2 The material use department, users and material control department are responsible for keeping and using the materials according to GMP requirements within their respective responsibilities. QA personnel monitor and manage the supply and warehouse, focusing on strengthening the monitoring and management of materials and finished products distributed and used according to the quota requisition.
1.3 Relevant management regulations shall be formulated for the procurement, storage, distribution and use of materials for pharmaceutical production. The raw materials used in drug production shall meet the prescribed standards and shall not have adverse effects on drug quality. Should be purchased from qualified units, and in accordance with the provisions of storage.
1.4 Strictly manage the materials to be inspected, qualified materials and unqualified materials. Unqualified materials should be stored in a special area with obvious signs that are easy to identify, and handled in time according to relevant regulations.
1.5 personnel at all levels of the company shall ensure that the raw and auxiliary materials used in drug production and the packaging materials in direct contact with drugs meet the quality standards of drug registration and shall not adversely affect the quality of drugs.
1.6 clear handling and management rules for materials and products shall be established to ensure the correct receipt, storage, distribution, use and shipment of materials and products, and measures shall be taken to prevent pollution, cross-contamination, confusion and mistakes.
1.7 all materials and products, such as receiving, waiting for inspection, sampling, storage, distribution and shipment, shall be handled in accordance with the operating procedures or technological procedures and recorded.
1.8 the transportation of materials and products should meet the needs of quality assurance, and the transportation conditions should be confirmed for materials and products with special requirements for storage and transportation conditions.
1.9 materials shall be purchased from suppliers recognized by the quality department, and the quality of major material suppliers shall be audited or evaluated. The supplier of changed materials shall conduct quality audit or evaluation on new suppliers, and the supplier of changed main materials shall also conduct relevant verification and stability inspection on products.
2 Expenditure budget
2. 1 according to the production plan, inventory situation and the needs of material procurement applications of various departments, prepare a budget plan and submit it to the competent leader of the company for approval at the end of each month.
2.2 The person in charge of the Material Control Department shall prepare the material procurement implementation plan according to the expenditure plan approved by the competent leader.
3. Application and ordering of materials
3. 1 Before 25th of each month, the heads of all departments shall review the names, specifications, quantities and uses of the materials ordered by their own departments according to the needs of production or work, fill out the Purchase Application Form in duplicate, and submit it to the Material Control Department after filling in one by one.
3.2 The person in charge of the Material Control Department shall further review the materials purchased by each department, ask the purchasing department for the reasons and reasons when necessary, and have the right to delete and adjust the purchased materials according to the inventory and actual use, and then report to the competent leader for approval.
4 material procurement
4. 1 The person in charge of the material control department gives the purchasing personnel the purchasing instruction of material classification. The procurement of raw and auxiliary materials and inner packaging materials that are in direct contact with drugs must be reviewed by the material supplier according to the corresponding SOP.
4.2 After receiving the purchase order, the buyer should carefully check the purchase order and implement the purchase in time.
4.3 For materials that cannot be purchased as planned, the Material Control Department must reply to the ordering department within one week after the competent leader approves the purchasing plan, and ask the ordering department to assist in purchasing if necessary.
5 Receiving of materials
5. 1 the material control department should have the operation procedures for receiving raw and auxiliary materials, packaging materials that are in direct contact with drugs and printing and packaging materials. All incoming materials should be checked to ensure that they are consistent with the order and come from suppliers approved by the quality department.
5.2 The outer packaging of materials shall be labeled with specified information and cleaned if necessary. If it is found that the outer packaging is damaged or other problems that may affect the quality of materials, it should be reported to the Quality Management Department for investigation and record. Each receipt shall be recorded, including:
5.2. 1 Name of materials indicated on delivery notes and packaging containers;
5.2.2 Names and/or codes of materials used by the enterprise;
5.2.3 Date of receipt;
5.2.4 Names of suppliers and manufacturers (if different);
5.2.5 Batch numbers of suppliers and manufacturers (if different);
5.2.6 The total amount of goods received and the number of packaging containers;
5.2.7 The batch number or serial number specified by the enterprise after receiving it;
5.2.8 Relevant instructions (such as packaging).
5.3 After receiving or producing, the incoming materials and finished products shall be managed in a timely manner according to the pending inspection until they are released.
5.4 Materials and products should be stored and turned around in batches in an orderly manner according to the nature of the materials and products under appropriate conditions stipulated by the enterprise to prevent pollution, cross-contamination, confusion and errors.
5.5 The warehouse keeper must carry out reasonable and effective warehouse management according to the corresponding material categories.
6 storage of materials
6. 1 Material storage is the responsibility of the Material Control Department, and the functions of each warehouse are reasonably divided and counted. Materials, intermediate products and finished products with special requirements for temperature, humidity or other conditions shall be stored according to the specified conditions. Solid and liquid raw materials should be stored separately, and attention should be paid to volatile substances to avoid polluting other substances.
6.2 Material storage must strictly implement the corresponding SOP and be monitored by the quality supervision department.
6.3 The Property Management Department shall make a reasonable inventory list of commonly used and reasonably consumed office supplies, spare parts and chemical reagents. If the inventory is insufficient, the supplier should be arranged to purchase in time.
6.4 Labels and instructions shall be kept, collected and distributed by special personnel.
6.5 The distribution and delivery of materials and products shall follow the principle of FIFO and FIFO in the near future.
6.6 Where computerized warehouse management is used, there should be corresponding operating procedures to prevent the confusion and errors of materials and products caused by special circumstances such as system failure and shutdown.
7 Distribution of materials
7. 1 Raw and auxiliary materials and packaging materials shall be distributed in strict accordance with the relevant SOP and according to the quota application form.
7.2 The distribution of labels and instructions, as well as the drug packaging printed with the same contents as the labels, must strictly implement the corresponding SOP, and be distributed according to the limited material requisition. The recipient should check the signature, and the sum of the use, damage and remaining quantity of the label should be consistent with the number of recipients.
7.3 The distribution of other materials must be approved by the department head and signed by the competent leader.
8 material inventory
8. 1 The property management department shall make a monthly inventory and statement of the current inventory, and report it to the company and the finance department.
8.2 The Property Management Department conducts a comprehensive inventory of the warehouse twice a year.