What is the GMP requirements for documentation?

What is the GMP requirements for documentation?

Documents must be approved, signed, and dated by the appropriate competent and authorized persons. Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly fashion and be easy to check.

What is GMP document control?

FDA regulations require GMP document control measures to ensure the integrity of SOPs, documents in the Design History File (DHF), batch records, employee training records, and similar documentation. The lack of GMP document control accounts for the majority of FDA Form 483s.

What are the general requirements that help in applying good documentation practices?

Basic requirements for good documentation practices will include, but not be limited to, the following components:

  • Accuracy.
  • Data Integrity (protected, secure and backed-up data systems)
  • Contemporaneous record-keeping (timely, immediately/real-time)
  • Legible.

Which of the listed document types are required GMP documentation?

There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of document.

What are the 5 main components of good manufacturing practice?

To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures (or paperwork).

What is SOP and GMP?

SOP-GMP is an essential part of the consistent replication of the tasks that are used to produce a regulated product to a pre-approved quality specification. Standard Operating Procedures are active documents that are routinely reviewed and amended as production processes are repaired, altered or replaced.

What are CGMP documents?

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

What are acceptable documentation practices?

Good Documentation Practices, commonly referred to as GDPs, are the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner. A key to Good Documentation Practices is to consider these questions each time you record your raw data: 1. Is it true?

What are 5 P’s of GMP?

What do Document owners need to know about GMP?

Document owners are required to ensure that the documentation and record systems for which they are responsible are specified in the form of detailed SOPs, including all aspects of documentation and records management as described above.

Which is the best course for GMP documentation?

Our 1-day GMP Documentation training course will help you to understand the practical day-to-day implementation of GMP requirements for documentation and records; including the current EU and USA GMP requirements for paper-based, electronic and hybrid systems.

How does mastercontrol work with GMP document management?

MasterControl Documents is an integrated part of the MasterControl quality management suite. MasterControl’s GMP document control software system automates all electronic document management processes to bring compliance and conformity in the system. Benefits of implementing an electronic document management software solution include:

Where can I get good documentation practice training?

You can complete the Good Record-keeping Practice (GRK) training online (good documentation practice) by clicking here. If your record-keeping practices and procedures are not up to current GMP and GDocP standards, you’re facing trouble.