USP, EP, BP, and IP Pharmacopoeial updates monitoring and timely implementation procedure

 1.0 OBJECTIVE 

To lay down the procedure for monitoring and timely implementation of applicable  pharmacopoeial updates of USP, EP, BP, and IP .

2.0 SCOPE

This SOP is applicable for the updates related to compliance and implementation in company Name.

3.0 BACKGROUND 

NIL

4.0 RESPONSIBILITY

4.1QA personnel to communicate the relevant Pharmacopoeial updates(IRA/RB/PF/USP/Ph.Eur & supplements) to AS & others personnel.

4.2 Head AS&QC will review the changes to specifications, methods and to propose the necessary action  and to initiate the revision of specification and standard test  procedure.

4.3Head QA or his designee to ensure compliance. 

5.0 PROCEDURE

5.1 QA personnel shall monitor the pharmacopoeial updates and relevant updates details shall be recorded in register for numbering of pharmacopoeial updates (Annaexure-1).

5.2 QA personnel shall inform to AS through the form “Communication of Pharmacopoeial updates” provided in Annexure-2 after the release/posting date into the main copy.

5.3 Numbering of Pharmacopoeial updates.

5.3.1 All Pharmacopoeial updates shall be identified with unique identification number.

5.3.2 Pharmacopoeial updates numbering shall consist of 10 characters.

5.3.3 First character “P” denotes company name.

5.3.4 Next two characters “PU” denotes Pharmacopoeial Updates.

5.3.5 Fourth character is “-“(hyphen).

5.3.6 The three characters are serial numbers starting from 001 for every year starting from January.

5.3.7 Eighth character is “-“(hyphen).

5.3.8 The last two characters indicates the year for e.g., 2022as 22. 

Example: First Pharmacopoeial updates numbering for the year 2022 shall be numbered as PPU-001-22.

5.4 Head QA or his designee shall call relevant personnel from AS to discuss about the Pharmacopoeial Updates within 30 days week of such information and feasibility of implementation shall be finished within 60 days.

5.6 Head QC shall evaluate the test method and AS personnel shall do the method verification for pharmacopoeial test method. Based on the method verification report, a change in an analytical procedure used for testing Method shall be implemented.

5.7 Revision of existing specifications and test procedure shall be done by following change control procedure. AS personnel shall raise the change control form. 

5.8 If the Pharmacopoeial method is not suitable or client intends to follow in-house methods, data supporting the equivalence or superiority of the in-house method shall be generated. After generating the data In-house method can be followed and those shall be marked as In-house methods in the specifications. 

5.9 In case of critical instrumental analytical method shall be verified for suitability before implementing in STP’s. If any difficulty/problem arises in the following Pharmacopoeial methods the same shall be notified to the concerned personnel as referred in Pharmacopoeia.

5.10 Based on the changes or newly added monographs Executive-QA shall identify the documents that have to be updated in line with Pharmacopoeia.

5.11 The executed documents “Communication of Pharmacopoeial Updates” shall be kept in QA office till relevant documents are revised.

5.12 Communication of Pharmacopoeial Updates for the monographs published in a forum which is not necessary for implementation shall be retained for maximum of one year from the date of receipt. 

5.13 Indian Pharmacopoeia: 

5.13.1 After each edition the updations are released with addendums on yearly basis, and are available in the form of books. 

5.14 United States Pharmacopeia:

5.14.1 USP is updated on a yearly bases (i.e.,) in the month of May every year. Adding to this any updation in the version is released under supplements with the same version number but separate attachments are released, these supplements are released twice yearly (i.e.,) in the months of August and December respectively. 

5.14.2 Once every version or supplements are released they are communicated through e-mails, publications and by updating in the official website. 

5.15 European Pharmacopoeia:

5.15.1 The European Pharmacopoeia (EP) is the national pharmacopoeia of the European union.  It is published for every 3 years, but every year they release three volumes.

6.0 VERSION HISTORY

7.0  ANNEXURES