SOP on Date and Time Format in Written Procedures

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1.0 Objective

To lay down a procedure for entering the date and time in all written procedures

2.0 Scope

This Standard Operating Procedure is applicable to all operational documents applicable at all pharmaceutical formulation plants / Operations of pharmaceutical formulation plant.

3.0 Responsibility

3.1 All concerned HODs shall be responsible for implementation of this SOP.

3.2 Head, QA shall be responsible for compliance of this SOP.

4.0 Abbreviations and Definitions

HOD                           –           Head of the Department

QA                              –           Quality Assurance

SOP                             –           Standard Operating Procedure

hrs                               –           Hours

Written Procedures     –           It includes current operational Standard Operation Procedures (SOPs), Specifications, Standard Testing Procedures (STPs), General Test Procedures (GTPs) , Product Development Report, Master Formula Records (MFRs), Technical Directions, Batch Manufacturing Records (BMRs), Annexure, Formats, Protocols, Reports, Labels, Change controls, Qualification & Validation Documents and other departmental documents.

5.0 Procedure

5.1 Date entry in all written procedures shall be done as follows:

5.1.1 First and second character shall represent the date “DD”.

5.1.2 The third character shall be dash “-”.

5.1.3 Fourth and fifth characters shall represent the month “MM”.

5.1.4 The sixth character shall be dash “-”.

5.1.5 Seventh and eight characters shall represent the year “YY”.

5.1.6 Date format notation DD-MM-YY. Example: 23-02-17, 23 shall represent date, 02 shall represent the month and 17 shall represent the last two digits of the year.

5.2 Time Entry in all written procedures shall be as follows

5.2.1 Twenty four hour clock shall be used for recording the time in all the written procedures e.g. if we want to write 1:40 PM instead of that we shall write 13:40hrs.

6.0 Forms and Records

None

7.0 Distributions

7.1 Master Copy                                        Documentation Cell (QA)

7.2  Controlled Copies                        Administration and Housekeeping, Agriculture, Clinical Research, Contract Manufacturing, Documentation Cell (R&D), Engineering, Exports, Finished Goods Warehouse, Human Resources & Development, Materials Management, Production, Quality Assurance, Quality Control, Regulatory Affairs, Safety Affairs & Stores

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

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