2/2/24, 10:46 AM Documentation errors Correction in Pharma

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Documentation errors Correction in Pharma

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 srikanth nagabiru  December 07, 2022
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1.0 OBJECTIVE

To lay down a procedure for correction of documentation error(s) occurred during documenting the data.
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2.0 SCOPE
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This procedure is applicable to all the drug products manufactured at XXX, Company.

3.0 RESPONSIBILITY Featured Post

3.1 Head-Quality Assurance

4.0 PROCEDURE

Sterility Test validation

 srikanth nagabiru  September 30, 2023

PROTOCOL APPROVAL Signing of this approval page o

indicates agreement with…

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USP 2023[USP 46 and NF 41

 July 26, 2023
4.1 In case if an error has been occurred during documentation, the same shall be corrected as follows:

4.1.1 Do not over write the wrong entry.

British Pharmacopoeia 202
 November 02, 2023
4.1.2 Strike it out with a single line.

4.1.3 Clearly write the correct entry near the wrong entry.
Retention sample or Contro
management sop
4.1.4 Sign and put the date on which the correction was made.
 July 23, 2023

4.1.5 Under no circumstances any artificial correction fluid shall be used to correct the wrong entry.
Analysis of Raw Materials –
 July 30, 2023
4.2 If An entire line or paragraph or page is to be deleted from a sequential record / document, the following
steps to be taken:

4.2.1 Strike it out with a line (Horizontal / Vertical) Water Content by KF

 November 30, 2012

4.2.2 Write a note explaining the reason for deletion.

Assay Calculation in HPLC


4.2.3 Sign and put the date near the strike out.
 September 23, 2012

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2/2/24, 10:46 AM Documentation errors Correction in Pharma
4.3 Based on the Quality of the product, errors are divided into two types;

4.3.1 Quality Impacting errors

4.3.2 Non Quality Impacting errors Sterility Test validation

 September 30, 2023

4.4 Quality Impacting Errors

4.4.1 A request shall be raised by the Initiator Department, if an error has been observed. The request shall be Calculation of Related Sub
raised in Annexure-I by giving the details of the error and its corrective actions. HPLC
 September 23, 2012

4.4.2 Concerned department Head shall give comments / Justification and request for the approval of the
correction. European Pharmacopoeia 1
 August 19, 2023
4.4.3 Head-QA shall approve the request for document ratification with comments.

4.4.4 After receiving the approval from Head-Quality Assurance, the concerned Head shall correct the error by Rinse water Analysis
signing on the date of correction made with cross check from Departmental Head sign & date.  October 27, 2022

4.4.5 The request for document ratification shall be filled along with the concerned document.

4.4.6 In absence of any Head, the Department Head shall write the Head name and the document shall be Random Posts
ratified.
EUROPEAN PHARMACOPOEIA 11.0
4.5 Some of the identified Quality Impacting errors are; 19.08.2023 - 0 Comments
The European Pharmacopoeia (Ph. Eur.) is
reference work for the quality control of m
4.5.1 Numerical numbers, which affect the final end, value result or yield. The…

4.5.2 Words or Phrase that give adverse meaning. DISSOLUTION BY HPLC VALIDATION M
08.12.2022 - 0 Comments
4.5.3 Over writing / whitening of letters / rubbing / artificial corrections of the entries. 1.0 OBJECTIVE:To provide general proced
Validation of Analytical test method for D
HPLC…
4.5.4 Wrong calculations that affect the final end value.
DISSOLUTION BY UV VALIDATION TES
4.5.5 Correction(s) required, if any, in any approved document. 08.12.2022 - 0 Comments
1.0 OBJECTIVETo lay down the procedure
of Analytical test method for Dissolution b
4.5.6 Formulae, which are typed wrongly in master document.

UNITED STATES PHARMACOPOEIA US

4.5.7 Any correction required in a document after release into the market.
21.11.2022 - 0 Comments
USP 2021 (United State Pharmacopeia 44
4.6 Non-Quality Impacting errors than 350 general chapters provide clear g
step…

4.6.1 Getting authorization from In-charge of the respective department can be used as correction. ASSAY OF COPPER SULPHATE
17.01.2023 - 0 Comments
4.7 Document Ratification Numbering System AIM:Determine the percentage purity of g
copper sulphate .REFERENCES:1. Practica

The numbering system shall be given as follows

XXXX/DR/000-00
Categories

XXXX indicates Company Code

 ANALYTICAL METHODS
DR indicates Document Ratification
 AR&D
000 indicates serial number of DR (Starts from ‘001-999’)

00 indicates last two digits of the Year (Eg: For 2022 i.e 22)  BOOKS

5.0 ABBREVIATIONS  DATA INTEGRITY

5.1 QA: Quality Assurance

 FR&D

6.0 ANNEXURE
 GUIDELINES
6.1 Annexure- 1: Request for quality impacting error ratification
 METHOD VALIDATION


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2/2/24, 10:46 AM Documentation errors Correction in Pharma

REQUEST FOR QUALITY IMPACTING ERROR RATIFICATION

[ANNEXURE-1]  MICROBIOLOGY
Document Ratification No: Date:
Initiating
Department
Initiator  PHARMACOPOEA
Department

Name of
Document
the  PRODUCTION
Document Batch
No.: Page No.: AR
No. /
No.
Initiation Date Actual Error Observed Corrective Actions
 QA-SOP
Initiated
(Sign
by &
Date)
 QUALITY CONTROL

 QUIZ

 STABILITY DATA EVALUATION

 STABILITY GUIDELINES

Page 1 / 1  STABILITY STUDIES

 STRESS TESTING
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 VALIDATION
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In-process control in Pharmaceuticals Artwork approval in Pharmaceuticals

Posted by: srikanth nagabiru

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ANALYTICAL METHODS AR&D BOOKS
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GUIDELINES METHOD VALIDATION

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 July 26, 2023 QUIZ STABILITY DATA EVALUATION

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