Identification management of pharmaceutical enterprises under GMP system
- Categories:Technical articles
- Time of issue:2023-02-02
Identification management of pharmaceutical enterprises under GMP system
- Categories:Technical articles
- Time of issue:2023-02-02
Identification management is an important means to trace materials, equipment and products. Effective status identification management can effectively prevent the occurrence of errors and confusion, to ensure the safety of product quality and patient medication safety, but also to ensure the personal safety of operators and production equipment operation safety.
In the last article we introduced the equipment management module of one of the six systems for GMP inspection. This paper will introduce the identification management module from the plant facilities identification management, equipment identification management, material identification management, clean identification management and other aspects.
Plant facility identification management
The zone status sign of plant facilities refers to the relevant information sign that can accurately and clearly display a certain article, area or room, including the name, specification, quantity and state (such as cleaning state, performance state, quality state and use state) of the article or room or area.
Naming of building
For easy identification, the name of a building should reflect its function, as well as its physical characteristics. As preparation building, QC building, administration building, etc. Each building should have a unique number (code), such as Preparation 1, extraction 2, warehouse 1, etc. Naming and numbering can use Chinese characters, also can use pinyin plus Arabic numerals, etc., eclectic, the key is to ensure its "unique". If the plant is large in scale, the road should also be considered to be named.
The name and number should be clearly marked
As for the name and number of the plant buildings and each function, it shall be marked in an appropriate way. The font color should conform to the characteristics between the building and the function. In the same building, the numbering and identification method should be basically the same.
Naming and numbering between functions
The naming between functions should conform to relevant specifications and pay attention to the uniqueness of numbering (code). For numbering issues between functions, a management file should be prepared for easy operation. The specific content contained in the number (code) can be set according to different circumstances of the enterprise. In order to ensure the uniqueness and identification of the number (code), building number (code) can be used as a prefix, that is, building number + floor number + functional location number (for reference).
Status identifiers are commonly used between functions
(1) Production status identification: process/post/operation room number/product name, batch number, quantity information, production stage, indicating production status.
(2) Clearance/cleaning status identification: the name of the post or operation room, the name of the last batch of products/materials/lot number, the product/materials/lot number to be produced in the next batch, clearance/cleaning date, expiration date, signature and other information.
Device identification management
Equipment identification can be divided into production equipment, public engineering equipment, inspection equipment and the identification of the instruments contained in these equipment.
Production device status identification
Production equipment status identification includes dynamic identification and static identification.
Dynamic identification refers to the identification that a production device is in the process of production, including the device number and the name and batch number of the product being produced.
Static identifier refers to the identifier that the device is in the non-production state, including the cleaning status and performance status of the device. Cleaning status indicators include cleaned and to be cleaned. The cleaned sign should indicate the cleaning personnel, cleaning date and expiration date. After replacing the product, changing the batch number of the same product, and continuous production in accordance with the predetermined procedures, cleaning shall be carried out in time. When not cleaned, the equipment should be marked "to be cleaned".
The performance status of the device is mainly used when the device is in abnormal production, including equipment maintenance, repair, and outage. The disabled equipment should be withdrawn from the production area in time. Special identification should be considered for devices in the verification state.
For the water system, purified air conditioning system, and air compressor system, at least "Running", "Standby", and "Fault" labels should be set on the host.
For fixed pipeline facilities, paint them with different colors according to the Marking Management Procedures for Process Pipelines. The name and flow direction of materials in the main fixed pipelines connected to the equipment should be marked so that the pipeline information is clear at a glance to avoid pollution, confusion and errors. The hanging position of pipeline identification mainly includes the starting point, ending point, crossing point, turning point of the valve and both sides of the wall hole of the pipeline.
In addition, the following ports of the pipeline need to be labeled with numbers: process water use point, sampling point; Public medium use point, sampling point; Valve identification, operating parts identification. The number (code) on the logo should take into account uniqueness.
Identification of inspection equipment
The status identification of inspection equipment is generally divided into good (running), unused, disabled, etc. Sound (operation) indicates that the instrument is in service condition, usually marked in green; Idle indicates that the instrument and equipment are not in use, usually marked with yellow; Out of service is usually a red sign, indicating that the equipment has broken down or damaged or has been retired, and needs to be repaired or withdrawn from the laboratory.
Measuring instruments, instruments and equipment shall be uniformly coded and managed by special persons. The label shall indicate its calibration status, including calibration date, expiration date, etc.
The measuring instruments, instruments and equipment shall have the weekly inspection certificate issued by the verification department, which shall be affixed to the observable parts of the measuring instruments, instruments and equipment. It shall be checked whether they are within the verification period before each batch of production.
Material identification management
The material identification usually needs to reflect the identity information of the material, the traceability of the material transfer, and the quality status of the material. The purpose of material labeling is to prevent confusion and error, thus avoiding contamination and cross contamination of materials and products. When the material identification is lost and the material cannot be identified, it should be handled according to the deviation procedure.
GMP requirements for material information identification
(1) Labeling requirements for raw materials and accessories
GMP requires that raw materials in storage areas should be properly identified and at least indicate the following:
① The specified material name and the internal material code of the enterprise
② The batch number set when the enterprise receives
③ Material quality status (such as to be inspected, qualified, unqualified, sampled)
④ Validity period or reinspection period, all ingredients used in the production of the same batch of products should be stored centrally and marked
(2) Requirements for identification of intermediate products and products to be packaged
Intermediate products and products to be packaged shall be clearly marked with at least the following information:
• Product name and internal product code
• Product lot number
• Validity period and reinspection period
• Quantity or weight (e.g. gross, net, etc.)
• Production process
• Production stage
• Product quality status (if necessary, such as to be inspected, qualified, unqualified, sampled)
(3) Requirements for the identification of unqualified materials, intermediate products, products to be packaged and finished products
Nonconforming materials, intermediate products, products to be packed, and finished products shall be clearly marked on each packaging container and stored securely in the isolation area.
(4) Requirements for labeling of packaging materials
Each batch or each distribution of packaging materials or printed packaging materials in direct contact with the product shall bear identifying marks indicating the name and lot number of the product used.
Use and management of material information identification
The enterprise shall establish written operating procedures for the management of material information identification, including the identification style of materials and products, the procedures for the issuance, use, destruction and control of material information identification and related records.
It should be pointed out in particular that the reception, distribution, use and destruction of material labels should be managed by special personnel and should be recorded; For the identification of other material information, the enterprise shall determine whether to establish receiving, distributing, using and destroying records according to the actual use situation, but there shall be management regulations on these material information identification.
The status labels of materials and products should reflect the historical status of materials, intermediate products, and products to be packaged. When changing the status of materials, the status labels should not cover all the original status notes.
(I) The use of material information labels
(1) Paste different information labels according to different stages of material use.
The usual practices are as follows: After the material has been preliminaryaccepted, if applicable, the label to be inspected or the identification plate to be inspected shall be pasted on the corresponding cargo space or area. According to the material management procedures established by the enterprise, after appropriate inspection and evaluation, the status of qualified or unqualified, etc., and appropriate identification. Material labels usually include material name, specification, material code, supplier lot number, internal lot number, production date, expiration or reinspection period, storage conditions, recipient/date, etc.
(2) Intermediate products Label intermediate products.
Usually include intermediate product name, code, lot number, expiration date or reinspection period, gross weight, net weight, production stage, etc.
(3) Product labels should be affixed when using unprinted blank large boxes, barrels or containers.
Product labels usually include product name, product batch number, specifications, production date, expiration date, package quantity, gross weight, size, storage conditions, manufacturing enterprise, manufacturing address, postal code, contact telephone and fax, transportation precautions, etc.
(4) If the finished product box/finished product container is not satisfied, the label of finished product zero box should be affixed.
The finished product zero box label includes product name, product lot number, product specification, production date, expiration date, quantity, operator and reviewer's signature/date.
(5) Waste should be attached with waste labels.
(6) Residual material should be pasted with residual material label.
The residual material label usually includes the product name, product lot number, product specification, production date, expiration date, quantity, operator and rechecker signature/date.
(7) Return goods should be affixed with the return label.
The return label usually includes the name of the return, the source of the return, the material code, the batch number of the return, the batch number of the return received, the manufacturing date, the expiration date, and the recipient/date.
Material information identification and material status identification should be pasted in appropriate locations and relatively concentrated, with a certain order or direction; Generally, it should be pasted near the product label of the original supplier to ensure that the product label information of the original supplier or the label information of the original material is complete, clear, and readable. However, it is necessary to distinguish the original label from the used label in an appropriate way, such as marking "X" on the label.
(8) Separate quarantine areas for inspection, nonconforming areas and return areas shall be adopted.
The corresponding area should usually have eye-catching status signs, and only approved personnel access, the corresponding area can be isolated by isolation fence, isolation network and other facilities (if necessary, can be locked); The area to be inspected, nonconforming area and return area can also be stored in separate closed storeroom. In this case, only area/space status sign plate or space status label can be set. However, there should be procedures to regulate the personnel access control, use and management of the above areas.
(9) Sampling labels are usually attached to separate packages/containers of materials and products after sampling is completed.
If the enterprise uses restrictive release label, it should be strictly controlled; And appropriate measures or procedures should be adopted to ensure that there is a significant difference with the qualified label, to avoid the wrong release of restricted release materials and products, misuse. Restricted release labels cannot be used for the production of official products, but are mainly used for other purposes such as research.
(10) Returns shall be stored in the return area after receipt and marked as pending.
According to the operation procedures of return management formulated by the enterprise, it shall be turned into qualified or unqualified state after inspection and evaluation, and transferred to the corresponding storage area.
(11) Materials with a specified period of validity shall be marked as nonconforming immediately after expiration of the period of validity and shall be disposed of according to nonconforming processing procedures.
(2) Management of material status identification
The quality management department of the enterprise is responsible for establishing and implementing the management process of receiving, distributing, using and destroying the qualified labels and nonconforming labels of materials and products, and deciding the transformation of the following quality states: the status to be inspected is transformed into the qualified state; The state to be inspected is turned into the unqualified state; The qualified status changes to the unqualified status.
For the quality status label pasting, or area and space quality status identification plate setting, according to the management process established by the enterprise designated the corresponding department/personnel responsible for implementation. The material management department is responsible for receiving, issuing, using and destroying the labels of materials and products under inspection. Be responsible for marking the status to be inspected, including marking the status to be inspected after receiving the returned goods; After receiving the incoming material, it is marked as the state to be inspected; The finished product that has not been released shall be marked as the state to be inspected after being stored; The abnormal storage of materials caused by deviation is marked as the state to be inspected.
Clean status sign
According to the object, there are three types of cleaning status identifier: device cleaning status identifier, container cleaning status identifier, and tool cleaning status identifier. The labels can be cleaned or to be cleaned.
The cleaned status identifier includes the name of the equipment/container/cleaning tool, cleaning person, cleaning time, expiration date, reviewing person, and remarks. The status identifier to be cleaned can simply mark the words to be cleaned, the person to be cleaned, and the time to be cleaned.
Device cleaning status identifier
After the production is finished, hang on the equipment to indicate the clean state of the equipment, indicating the equipment is clean or not clean, using the color code method, green is "clean", red is "to be cleaned". According to the workshop equipment cleaning regulations, the cleaning period is 4 hours.
If the device is not used for a long time (for example, more than two weeks), you can hang the Idle Device status label instead of the cleaning label.
After the equipment is cleaned, it is still necessary to maintain the surface and inner wall of the equipment under idle state. To "idle" is not to stop cleaning.
Container with clean status marker
Use color scale management, respectively green and red, red means "to be cleaned", green means "cleaned". All production containers should be hung with container cleaning identification card, such as press cloth, joint, measuring cylinder, etc. However, not all the utensils used to hold the articles use the container cleaning label, and some cleaning utensils need to be hung with the sanitary tool cleaning label card. According to the document, all production tools should be numbered. For the small tools and containers that are difficult to hang, the same category can be numbered and an identification card can be hung.
Cleaning tool cleaning status
According to the document, the cleaning tools should be cleaned immediately after use, and the state of the tools should be marked as "cleaned" or "to be cleaned". Remove the clean status identification card when using the tool. According to the document, all tools should be numbered. For the cleaning tools that are not easy to attach cleaning labels, you can number the same type and attach an identification card.
Matters needing attention
(1) Because the cleaning status sign is hung in the workshop, it should be made of material that is strong, not easy to fall off, not easy to moldy, not easy to rust, not easy to electrostatic.
(2) The cleaned and to be cleaned status signs can be made in the way of one and two sides.
(3) The rooms, equipment and appliances that hang the status mark to be cleaned, do not hang the status mark to be cleaned, or display the status mark to be cleaned beyond the validity period shall not be used.
Correct identification is to ensure that GMP production activities in the machine, material, clean state and other elements always maintain a good control condition, is also the enterprise to avoid errors and confusion, avoid pollution and cross pollution, improve the quality management level of the effective practice.
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