Regulatory requirements of handling

This information is not all-inclusive. Please consult your company s QA executive, legal counsel, quality advisory team, recall procedure, or the specific regulatory requirements for handling a recall in the Code of Federal Regulations (21 CFR 7). 

In the United Kingdom many of the offshore regulatory requirements are handled through the Prevention of Fire and Explosion, and Emergency Response (PFEER) Regulations. They require that duty holders provide adequate arrangements for escape, evacuation, rescue, and recovery of persons involved in an incident. 

Established Practices Codes, standards, regulatory requirements, industry guidelines, recommended practices, and supplier specifications have all developed over the years to embody the collective experience of industry and its stakeholders in the safe handling of specific materials. These should be the engineer s first resource in seeking to design a new facility. 

Once the manufacturing projection questions have been answered, a manufacturing philosophy must be decided on. This includes deciding on documentation requirements, special materials handling, controlled substance security, cleaning validation criteria, and equipment and facility qualification requirements. Now that we know what types of batches are to be manufactured, we can be more detailed in the description of the requirements of the facility. These requirements may be based on internal as well as regulatory requirements. In fact, if a full-scale facility is already in place, this step can be completed fairly easily and quickly. Many of the policies and systems may be transferred directly into the pilot facility. And others may be transferred with only slight modifications. 

Classification and segregation of wastes by such criteria are essential for their safe handling and disposal. If the waste is not a common chemical with known characteristics, enough information about it must be supplied to satisfy regulatory requirements and be certain that it can be handled and disposed of safely. For many wastes, only the principal components must be specified. However, if the waste contains a carcinogen or toxic metal, this information should be supplied. The information needed to characterize a waste also depends on the method of ultimate disposal. 

Functionality that handles electronic records subject to specific regulatory requirements should be specifically identified in the URS. Individual records requiring ERES controls should be defined. The following aspects should be outlined for either the entire set of electronic records or a subset or for individual electronic records (a detailed discussion is provided in Chapter 15), as appropriate ... 

---