To lay down a procedure for entering the date and time in all written procedures
This Standard Operating Procedure is applicable to all operational documents applicable at all pharmaceutical formulation plants / Operations of pharmaceutical formulation plant.
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.
5.1 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
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
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