Preparation process documentation

After preparation, a checklist may be used by less expert engineers than the preparers for inspecting the process areas to compare the process equipment and operations with the checklist oidrcr on hardcopy or laptop computer. The analyst fills in the checklist according to observations from their inspection, process documentation, and interviews with operators and their perceptions. 

Planning new documents, funding, prior authorization, establishing need, etc. Preparation of documents, who prepares, drafting process, text, diagrams, forms, etc. Standards for the format and content of documents, forms, and diagrams Document identification conventions Issue notation, draft issues, post approval issues... 

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. 

The Center for Chemical Process Safety expresses sincere appreciation to the members of the staff of TNO Prins Maurits Laboratory, Rijswijk, The Netherlands, who prepared this document. Special recognition is given to the following staff members ... 

Determine product variability under constant processing conditions Prepare process transfer documents Finalize product specifications... 

For example, most companies would rather reference their supporting documents than have FDA ask whether or not a particular document exists. Further, this practice will assure that the company has actually taken sufficient time and prepared the document referenced. There are those companies that prefer to voluntarily attach the documents rather than just reference them. This may not be in the best interest of CGMP manufacturers for two clear reasons. First, attaching every development report, every batch record, every analytical method, every support protocol/report and so forth will make a process validation document—a hefty document to begin with—too big to read. Second, volunteering any information is considered very dangerous, as it is very rare for a company to have no dirty laundry. Why hang it out for FDA or any audience to see ... 

Table 5.6 also defines responsibilities. The Originator responsibility is preparing a document or record, Review responsibility is confirming technical content and consistency with other validation activities, and Approve responsibility is authorizing the activity as complete and correctly documented. The Quality Unit may at its discretion, as part of its approval process, review or audit supporting and referenced deliverables. Due account must also be taken where a Supplier Audit determines that the pharmaceutical or healthcare company should take over a lead responsibility for a supplier s documentation responsibilities. The review and approval roles presented in Table 5.6 are consistent with the review of regulatory expectations presented in Chapter 14. 

Some organizations, including the Canadian Health Protection Branch and the United States Pharmacopeia (USP), act as observers to the conference working committees, and their input is also influential in the guideline-setting process. In addition, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) acts as an umbrella organization and provides the ICH secretariat to coordinate the preparation of documentation. 

Where process water is used as an ingredient or as the infeed for further purification for the manufacture of sterile goods (see Part 2), a Water Quality Manual (or Water Quality Section of a Quality Manual) should be prepared. This document should include ... 

Update the process documentation and prepare future investments. 

Documentation in the hidden factory has its own production process. The raw material of paper is prepared into documents and data entry forms as production plans, master production and control records, batch records, raw material sheets. Standard Operating Procedures (SOPs) and so on, which in turn are enhanced with more and more manual data entry and signing at each step of activity with approvals. The paper flows from desk to desk as collections of related documents. There is a huge "add ingredient" or "assembly" process of data to the physical medium, which at each step of activities has to be at the right place at the right time—just as the physical products. 

A process to confirm adequate preparation and application of controls prior to authorizing work at the activity level should be carried out by a qualified multidisciplinary team. First line supervisors should team with employees and safety and health professionals to ensure the activity-level hazards and controls needed to establish a safe working envirorunent. The hazard and complexity of work should determine the formality and rigor of the review process, documentation, and level of authority for agreement. 

PERFORMING THE ANALYSIS. After a checklist is prepared, it can be applied by less experienced engineers if necessary. Team members should walkthrough and visually inspect the process areas to compare the process equipment and operations to the checklist items. The checklist can be reviewed in either hard copy or computer-based form. The analysts respond to the checklist items based on observations from their visual inspections, process documentation, interviews with operating personnel, and personal perceptions. If the process... 

The Basis for Interim Operation (BIO) document for K>Reactor in Cold Standby and the L- and P-Reactor Disassembly Barins was pr ared in accordance vrith the draft DOB standard for BIO preparatiott (dated October 16, 1993). The actives for tte BIO preparation process included hamd iden carion, hazard categorization, and a preliminary hazards analysis. These actmties, along with the review of the K-Reactor Safety Anafysis R rt (SAR), K-, and P>Reactor Technical Spedfications (TS), K-Reactor Cold Standby Plan, L-Reactor ( Id Shutdown Plan, P-Reactor Standby Plait, and other safety documents, were used to compile the BIO. 

The Q8 guideline emphasises the importance of understanding the formulation and the method of preparation, as well as preparation process control that is based on scientific data and risk analysis of the preparation process (see also Chap. 21). Identification of all relevant sources of variability will result in a window (the design space) for all adjustable parameters (particle size, pH, mixing time, etc.). Practically, the QbD approach will lead to a robust formulation and preparation process that is stUl flexible enough to adapt to necessary modifications. Detailed documentation of the development research will help limiting time- and resourceintensive follow-up studies in order to explain process deviations or applying process modifications. 

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