回收酒精的批号

一一

关于回收酒精有两个问题：
1.批号你们是怎么定的？
2.如果醇沉中投入一批回收酒精加一批酒精或者是两批回收酒精，这次醇沉后回收的酒精的批号应该如何定？

youngzhou

可以不用批号，用检验控制号可进行追踪

kkcljj

批号（管理号）的定义，应有文件规定，并在批记录中体现。


Guidance for Industry
(Continued)

Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients

Draft - Not for Implementation

V. CONTROL OF RAW MATERIALS

A. General Controls

Written procedures should be established describing the purchase, receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of raw materials. Such procedures should be followed.

Raw materials should be handled and stored in a manner to prevent contamination and cross-contamination. Bagged and boxed raw materials should be stored off the floor and suitably spaced to permit cleaning and inspection. Raw materials that are stored outdoors should be in suitable containers. Identifying labels should remain legible and containers should be appropriately cleaned before opening to prevent contamination.

For solvents or reagents delivered in bulk vessels (e.g., tanker trucks), a procedural or physical system, such as valve locking or unique couplings, should be used to prevent accidental discharge of the solvent into the wrong storage tank.

Each container or grouping of containers of raw materials should be assigned and identified with a distinctive code, lot, or receipt number. This code should be used in recording the disposition of each lot. A system should be in place to identify each lot’s status. Large containers (e.g., tanks, silos) that are used for storing raw materials, including their attendant manifolds, filling and discharge lines, should be appropriately identified.

B. Receipt, Sampling, Testing, and Approval of Raw Materials

Upon receipt and before acceptance, each container or grouping of containers of raw materials should be examined visually for appropriate labeling, container damage, seal integrity (where appropriate), and contamination. Raw materials should be held under quarantine until they have been sampled, tested or examined, as appropriate, and released for use.

Representative samples of each shipment of each lot should be collected for testing or examination in accordance with an established procedure. The number of containers to sample and the sample size should be based upon appropriate criteria (e.g., raw material variability, confidence levels, degree of precision desired, past quality history of the supplier, and the quantity needed for analysis). Raw material containers selected for sampling should be opened, sampled, and resealed in a manner that prevents contamination of their contents and of other raw materials. Sample containers should be properly identified.

At least one test should be conducted to verify the identity of each raw material. A supplier's certificate of analysis might be used in lieu of performing other testing provided that the manufacturer has a system in place to evaluate vendors and establishes the reliability of the supplier’s test results at appropriate intervals. For hazardous or highly toxic raw materials, where on-site testing may be impractical, suppliers’ certificates of analysis should be obtained showing that the raw materials conform to specifications. In addition, the identity of these raw materials should be confirmed by examination of containers and labels. The lack of on-site testing for hazardous raw materials should be documented.

C. Use and Reevaluation of Approved Raw Materials

Approved raw materials should be stored under suitable conditions, and where appropriate, rotated so that the oldest stock is used first. Raw materials should be reevaluated, as necessary, to determine their suitability for use (e.g., after prolonged storage or after exposure to heat or high humidity).

D. Rejected Raw Materials

Rejected raw materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

E. Control of Recovered Solvents, Mother Liquors, and Second Crops

Written procedures should be established for the recovery of solvents, mother liquors, second crops or other materials. These should include adequate tests and controls to ensure that recovered materials are suitable for use in manufacturing processes and do not adversely affect the quality of APIs and intermediates.

Solvents may be recovered and reused in the same process or in different processes, provided that the recovery procedures are validated to ensure that recovered solvents meet appropriate standards before reuse or commingling with other approved materials. The quality of solvent mixtures should be monitored at suitable intervals.

Mother liquors may be reused provided that the quality of the API or intermediate is not adversely affected by their reuse. Procedures for secondary recovery of reactants, intermediates, or the API should ensure that these recovered materials meet specifications suitable for their intended use.

The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented in batch production records.

F. Process Water Quality

Water used in the production of APIs should be routinely tested and, at a minimum, meet the standards for potable water, as stated in the United States Environmental Protection Agency's (EPA) National Primary Drinking Water Regulations (NPRDWR) or comparable standards of other authorities such as the European Union, Japan, or the World Health Organization. The potable water supply, regardless of source, should be assessed for chemicals that may affect the API process. Information should be periodically sought from local authorities concerning potential contamination by pesticides or other hazardous chemicals.

Water of suitable quality, with tighter chemical and microbiological quality specifications, should be used during certain process steps (e.g., cell cultures, final crystallization and isolation) and during early process steps if impurities that affect API quality are present in the water and cannot be removed in later steps. For example, if water is used for a final wash of a filter cake, or if the API is crystallized from an aqueous system, the water should be suitably treated (e.g., deionization, ultrafiltration, reverse osmosis, or distillation) and routinely tested to ensure compliance with appropriate chemical and microbiological specifications. If used for final rinses during equipment cleaning, the water should be of the same quality as that used in the manufacturing process.

Water used in the final isolation and purification steps of nonsterile APIs intended for use in the preparation of parenteral products should be tested and controlled for bioburden and endotoxins.

Where water is treated to achieve an established quality, the treatment process and associated distribution systems should be qualified, validated, maintained, and tested following established procedures to ensure water of the desired quality.

咕咕

kkcljj 发表于 2013-2-19 16:19
批号（管理号）的定义，应有文件规定，并在批记录中体现。

能否译成中文？

freeman132

英文的东西，没看习惯，确实也有点晕{:soso_e115:}

hkj456@tom.com

这个批号我觉得你可以自己规定吧，只要可以跟踪整批批号的来源，去向，还有配套的检验就可以吧！这个也有很高要求吗？