Recall, documentation

Is there a documented procedure for recalling material from a customer ... 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

This technique sets out to collect data about near-incidents or critical events that have been experienced by the operating team but that are unlikely to be documented. The basic premise of the technique is that events that could have led to serious consequences would tend to be remembered by the workers. Through individual or group interviews, significant events are recalled which are then analyzed in order to generate useful information about the difficulties involved in the performance of a task, the adequacy of the operating procedures, any problems with the equipment or control panel design and so on. The technique can be used in three areas ... 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

A system of documentation should exist such that the history of each batch of the product, including details of starting materials, packaging materials, and intermediate, bulk and finished products, may be determined. Distribution records must be kept. This information is of paramount importance should a defective batch need to be recalled. 

I recalled again the freed workers in the Farben administration building at Frankfurt, burning records to keep warm — and, later, the wood-burning trucks moving under Ernst Struss s direction from that building to the new document center at Griesheim. I mentioned these events. Half-hopefully, I said "You don t think there s any chance they vanished at that time "... 

A. I can no longer recall and I can t see any connection. I think it is possible that at times I would see them and at other times I would not. You have submitted two documents here. Speaking of 15051, I would like to say that it was the normal monthly report for October 1943. 

Recalling the demands on the polymer architecture of a polymer brush and the projected properties in terms of swelling, wetting and friction, as described in the theoretical work, the brush has to consist of linear polymer chains of the same length at high grafting densities. The closest approximation to this can be obtained by the living anionic SIP (LASIP). The experimental difficulties outlined mean that only relatively few examples of LASIP are documented in the literature. 

Witnesses should be provided documents pertinent to their statements and allowed time to review them before or during the interview. The documents may help the witness recall information that otherwise would be forgotten. Asking the witness to sort out any apparent inconsistencies in his recollection and information contained in documents before committing to a recorded version is a practice to consider. This avoids statements that he may later have to modify or retract. 

As shown in Tables 6-8 the Indian GMP regulations consists of eight parts I, IA, IB, IC, ID, IE, IF, and II. Part I covers the general requirements of GMP. It is divided into 29 chapters, which deal with the requirements for personnel, premises, equipment, sanitation, production and process controls, materials, documentation, quality management, validation, reserve samples, recalls, complaints, and self-inspection. Parts IA to IE cover specific requirements for the manufacture of different dosage forms regarding premises, equipment, and methods. Part IA deals with the require-... 

As shown in Table 10 New Zealand s own GMP code consists of five parts. The first part covers the manufacture of drug products and the second part the manufacture of blood products. Part 3 covers compounding and dispensing, including compounding of sterile drug products. Part 4 deals with wholesaling and Part 5 with product recalls. Parts 4 and 5 are combined in one document [31]. 

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

Correspondences in EU GMP Code In the EU GMP code [15] issues related to holding and distribution are covered in Chapters 4 (Documentation), 5 (Production), and 8 (Complaints and Product Recall). Correspondences to regulation... 

Correspondences in WHO GMP Guideline In the WHO GMP guideline [36] issues related to holding and distribution are covered in Chapters 6 (Product Recalls), 14 (Materials), 15 (Documentation), and 16 (Good Practices in Production). Correspondences to regulation 211.142 are covered in Subchapters 14.4,14.26, and 16.2, which state the requirements for the storage and quarantine of products. Correspondences to regulation 211.150 are covered in Subchapters 6.1-6.8,15.45, and 16.2, which state the requirements for distribution and recalls. 

At least three production batches should be selected for thorough analysis to include (a) traceability of all components or materials used in the subject batches, (b) documentation of raw material or component, in-process, and finished goods testing for the subject product batches, and (c) warehousing and distribution records as they would relate to a possible recall. 

Change control is absent or inadequate. Most errors are introduced into a system after changes are made without authorization, documentation, and revalidation. For example, FDA s principles of software validation [3] state in Paragraph 2.4 Of those software related recalls, 79% were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. 21 CFR Part 11 validation guidance also states the following ... 

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