Documentation errors Correction in Pharma

1.0 OBJECTIVE

To lay down a procedure for correction of documentation error(s) occurred during documenting the data.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at XXX, Company.

3.0 RESPONSIBILITY

3.1 Head-Quality Assurance

4.0 PROCEDURE

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.

4.1.2 Strike it out with a single line.

4.1.3 Clearly write the correct entry near the wrong entry.

4.1.4 Sign and put the date on which the correction was made.

4.1.5 Under no circumstances any artificial correction fluid shall be used to correct the wrong entry.

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)

4.2.2 Write a note explaining the reason for deletion.

4.2.3 Sign and put the date near the strike out.

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

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 raised in Annexure-I by giving the details of the error and its corrective actions.

4.4.2 Concerned department Head shall give comments / Justification and request for the approval of the correction.

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 signing on the date of correction made with cross check from Departmental Head sign & date.

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 ratified.

4.5 Some of the identified Quality Impacting errors are;

4.5.1 Numerical numbers, which affect the final end, value result or yield.

4.5.2 Words or Phrase that give adverse meaning.

4.5.3 Over writing / whitening of letters / rubbing / artificial corrections of the entries.

4.5.4 Wrong calculations that affect the final end value.

4.5.5 Correction(s) required, if any, in any approved document.

4.5.6 Formulae, which are typed wrongly in master document.

4.5.7 Any correction required in a document after release into the market.

4.6 Non-Quality Impacting errors

4.6.1 Getting authorization from In-charge of the respective department can be used as correction.