Good Documentation Practices Relating to USP

[John Robinson]

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.

US Pharmacopeia (USP) has laid out a series of GDP’s. One of the major new updates is contained in the newly proposed USP-NF General Chapter <1029>.

Basis for GDP in USP

GDP for USP is also formulated on the same principle and rationale on which any GDP is built: proper, accurate and comprehensive records are the backbone to proper documentation, which is the basis for all major and minor procedures and operation.

GDP for USP has guidelines in the General Chapter 1029. These guidelines are given with the intention of helping build a foundation for the Quality Systems, apart from also ensuring the integrity and control of documents.

These GDP’s are meant for use in the production and control of the following:

• Active pharmaceutical ingredients (APIs)
• Medical devices
• Excipients
• Pharmaceutical products
• Dietary supplements
• Food ingredients

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

In what areas are GDP’s listed out in Chapter 1029?

GDP’s for USP are mentioned in relation to electronic and paper records, which include reports, raw data, protocol, and procedures concerning analytical data and manufacturing controls, and has recommendations on the kind of information that should be recorded for different kinds of documents that require GMP. A prominent amendment brought into the new chapter 1029 is that there is no longer a distinction between instructions and records, and all records and instructions are broadly merged into “records”.

Some broad requirements of GDP as set out in Chapter 1029

USP Good Documentation Practices spell out a number of principles. Some of these include:

• There should be clarity, accuracy, conciseness and legality of records
• Every time an action is performed, there should be a documentation
• Anyone dealing with documents should not backdate or postdate any action
• The initial of the person who carried out a change should attest her initials and offer an explanation whenever an amendment is made

Electronic or manual records should go by the following GDP’s:

• Any data entry should be traced back to the person who did the entry
• Shorthand notations are not allowed
• Controls should be put in place to ensure integrity of the record
• When a thermal paper is used, a verified copy of its accuracy should be retained, and the user should initial it with the date