Compliance documents

Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records Electronic Signatures, FDA, 2003 (http //www.fda.gov). Validation/compliance documents found under the Parenteral Drug Association (PDA) (http //www.pda.org). 

Level Type of change Compliance documents Regulatory filings Compliance challenges... 

Other compliance The control of a prodnction facility using PLCs also has ramifications for compliance with other statntory regnlations such as health and safety legislation and environmental regulations. Addressing all of these requirements in one validation stndy can help to focus effort and resonrces at the appropriate time. In addition, one set of documentation, properly written, approved, and controlled, can minimize dnplicative work. Some companies prefer to keep separate compliance documents for each regnlatory body. This is a matter of choice. 

Compliance documents are needed, in addition to the regulatory and research documents, to demonstrate the integrity of the data. Compliance documents refer to those reports required by GMP and/or utilized during the course of inspection by a health authority (Chapter 15). 

Typical analytical compliance documents are discussed in the following sections. 

The following list contains relevant CMC guidances, draft and final, related to the regulatory and compliance documents required by the FDA for U.S. submissions and by the ICH for international dossiers. Although some of the listed guidances are in draft form, they represent FDA s current thinking and are useful references. 

The Renovation, Repair, and Painting Rule requires renovators to create certifications and keep records that demonstrate compliance with the each detail of the renovation rules for three years, or longer if required by another law7 In practice it is important to retain compliance documents for longer, and the exact length of time depends on the state in which the renovator operates. In most jurisdictions the statute of limitations for a tort action brought by a person who was a child at the time of an injury can be extended beyond the time that would have been allowed for an adult to bring a tort action.In any event records should be maintained for the five years of the TSCA statute of limitations. ... 

Omitting information and/or making false statement in any application, label, manifest, record, report, permit, or compliance document... 

OSHA requires employers to retain written information regarding medical evaluations, fit testing, and the respirator plan effectiveness. Maintaining this information promotes greater employee involvement and provides compliance documentation. Employers must retain a record for each employee subject to medical evaluation. This record includes results of the medical questionnaire and, if applicable, a copy of the healthcare professional s written opinion. Maintain records related to recommendations including the results of relevant examinations and tests. Retain the records... 

Obtain all compliance documentation and supporting data Technical Construction Eile (TCP), SEMI S2/S8 reports, compliance letters, tool manuals, required certifications, etc. 

For simple and nearly identical facilities within the same area (such as well jackets and single well caissons), a common compliance documentation package may be compiled, except that documentation must reflect site-specific deviations from the norm for facilities within the area. 

Assemble PSSR compliance documentation or conduct field checks of physical activities required for the triggering event. 

EPA has proposed a rule to require electronic reporting under Section 313 of EPCRA. While the rule hasn t been finalized, EPA now makes all TRI forms, instructions, guides, and other compliance documents available online at www.epa.gov/tri. 

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