This article is helpful to understand the terminology of addendum, errata, attachment, format, annexure, exhibit, amendment, corrigendum. These all concepts are used in the pharmaceutical industry.
1.0 Addendum / Addenda
Addendum word is established from the Latin word “addendus” and the meaning of addendus is “must be added”. Addenda is a plural form of addendum. An addendum is indicating the information is added related to the original records or material or published articles. This document is placed at the end of original records or material or published articles.
An addendum is mostly used when:
1. Additional information is not required in original records, documents, data but provides more depth to the subject.
2. Author wants to add more information related to the original records, documents, content, but does not want to change original data.
2.0 Errata / Erratum:
Erratum word is established from the Latin word “Errata” and the meaning of errata is an “error, mistake”. Errata is plural form of erratum. If any error occurs by publisher during publication in a legal or computerized document, then erratum is issued to correct the error by the publisher.
Errata document contains correction of error and publisher place this errata document at the end of original data, record, document, article. Errata is highlighted to the author as proof before final publication.
These all correction is covered by the publisher in the next printing work.
Errata is mostly used during the compliance report. After submission any error is observed by the industry or regulatory body.
3.0 Corrigendum:
Corrigendum word is established from the Latin word “corrige, Corrigenda” and the meaning of corrige is an “correction”. Corrigenda is plural form of corrigendum. If any error occurs by the author, then corrigendum is issued to correct the error by the author.
Author place this corrigendum page before or after the error page, data, record, document, article for a single error.
If more errors are found on pages, then the corrigendum page is placed at the end of the article, data, record.
These all correction is covered by the publisher in the next printing work.
4.0 Attachment:
Attachment is established from the French word “Atachier”. The meaning of atachier is “to attach”. Attachment is a universal term that refer to the main document that may or may not be linked with the original document. This is a separate or independent document. Attachment acts as supplementary or referral document to the main document.
Attachment may contain Process flow chart, table, provide additional or extra information due to space limitation. Attachment is placed at the end of the main document or after the data, record, as per the requirement.
5.0 Appendix:
The term appendix is established from the Latin word “appendere”. The meaning of appendere is ‘hang upon’. An appendix is set of attachments or a single attachment which explains the facts mentioned in the main document. The plural of appendix is appendices. Appendix acts supplementary or referral document to the main document.
Appendix may contain map, layout, table, graphs, etc. Appendix is place at the end of the record, data, main document. Appendix term is most popular in the United Kingdom.
6.0 Annexure:
The term annexure is established from the Latin word “annexus”. The meaning of annexus is ‘tied to’. Annexure describes the additional information about the original data. Annexure is act as attachment but provide brief description about the data, record, article which may people like to read.
7.0 Exhibit:
The term exhibit is established from the Latin word “exhibitum”. Meaning of exhibitum is ‘to display or to show’. Exhibit is used to show of data, document, record publicly. Exhibit is act as supplementary or referral document to the main document. Exhibit term is most popular in the United State (US).
Exhibit include flowchart, layout, pictogram etc. Exhibit is placed at end of the original data.
8.0 Format:
Format is a document arranged step by step for the recording of data. All generated data is recorded and maintained in the format. Most formats are part of Standard Operating Procedure (SOPs).
Format may be available in theoretical, table etc. form for the recording of results generated by system or after calculation.
9.0 Amendment:
An amendment is based on the word “to amend” means “to change for better”. An amendment is alteration, change (addition or deletion) or modification in the existing term, content or provision. Amendment is attached with the original document.
Amendment is used in official documents, law / Constitution.
Below is the table to understand the terminology in better way:
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SOP on Annual Product Quality Review (APQR)