What is the GMP standard?

Table of Contents

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

What is considered a GMP document?

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. Reproduced documents must be clear and legible.

How do you correct an error in a GMP file?

Correct mistakes as quickly as possible. Do not black out, obscure or erase the mistake – the original data must be readable! Do not partially cross out mistakes; always draw a line though the mistake. Do not use correction fluid, erasers, or tape.

What are the 5 elements of GMP?

Good manufacturing practices (GMPs) help 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 the difference between ISO and GMP?

ISO is considered a business-focused standard that always enforces effective management of internationally considered best prices. GMP is considered practices that are required for ISO to conform to guidelines recommended by agencies.

Are GMP documents legal?

They provide legal evidence that the company followed GMP. There are many cases where in a legal dispute, the GMP-related records are used in court to verify that the company followed GMP. They are used to investigate product complaints/adverse events.

Which sops are required by GMP?

GMP Standard Operating Procedures (SOP)

1.1 Quality Assurance (QA) Management Procedures.
1.2 Quality Control Laboratory Procedures.
1.3 Microbiology (Sterility) Laboratory Procedures.
4 Process, Cleaning and Methodology Validation Procedures.
1.5 GMP | Manufacturing and Packaging Procedures.

Can nurses use white out?

Always draw a line through the incorrect entry, write the correct information and initial and date the correction. This makes clear what was originally written and what was added. Never use white-out or scribble over the entry because it fuels suspicion about what the original entry might have been.

How do I make corrections to a legal document?

Proper Error Correction Procedure

Draw line through entry (thin pen line). Make sure that the inaccurate information is still legible.
Initial and date the entry.
State the reason for the error (i.e. in the margin or above the note if room).
Document the correct information.

What are the basic principles of GMP?

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any food, cosmetic or pharmaceutical production that cannot be eliminated through testing the final product.

What is good documentation practice in GMP?

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents. The importance of documentation: As per GMP documentation control “If it is not written down, then it did not happen”.

Can you leave a blank page in a GMP report?

Do not leave blank space in any GMP record. Blank spaces or pages shall have a single line through them with a signature and date and the reason for the page is blank (e.g. “Not Applicable”, “NA” or “N/A”).

What should you never do with GMP Records?

Never use scratch papers, loose papers or “post it” to record the data. Never discard or destroy any GMP record unless retention period expiry is reached. Documentation and records used throughout the manufacturing process, as well as supporting processes, must meet the basic requirement of GDP.

How to maintain the list of GMP impacting forms?

QA maintains the list of GMP impacting forms and its associated SOP. 3. Records for issuance and retrieval of such forms should be maintained. 1. Time should be entered in 24:00-hour cycle. Record the time in HH: MM format. For Example 11:05 AM should be written as 11:05 and 11:05 PM should be written as 23:05. 2.