1.1 To lay down a standard procedure for requirements while filling any documents.
2.0 SCOPE
2.1 This SOP shall be applicable for the procedure to be followed for Good Documentation Practices (GDP) in the Department of Quality assurance (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head-QA
3.2 All personnel involved in writing any documents
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 All personnel shall use a blue ink ball pen for signature and other documentation. Do not use a red ink pen for recording purposes. Gel ink pen shall not be allowed for documentation and signature purpose.
5.2 The date shall be written as dd-mm-yyyy or dd/mm/yyyy unless otherwise specified in the individual SOP.
5.3 The time shall be written in 24 Hours format e.g. 01:25 pm shall be written as 13:25 Hrs.
5.4 Wherever signatures are applicable, the signatures shall be done the same in all documents. However, both initial and full signatures shall be acceptable.
5.5 If by mistake a wrong entry is made, cut the entry with a single line so that the wrong entry can be readable and write the correct entry with the sign. Do the correct entry just above or beside the wrong entry immediately. Do not use an eraser or whitener to correct any error.
5.6 If documents get damaged (by spillage or any other reason), always retain the original document and rewrite the data in the new record. Keep the original document along with rewritten document with QA approval.
5.7 If multiple options are given, cross out the option which is not required. For example, selection of result, Complies / Does not Comply.
5.8 Fill the entire column given in format or annexure, if some activity/operation not carried out then make a diagonal line from top left to bottom right.
5.9 Ensure that the blank formats and protocols, in which the results are to be entered, are issued by the QA department.
5.10 Prepare and use formats/protocol only as per their respective standard operating procedures.
5.11 Attach or preserve the filled formats/protocols in the respective reports and in turn preserve these reports in the dedicated file.
5.12 Enter the details in the respective logbooks/ registers as soon as that particular operation is done.
5.13 Fill the raw data sheet online while performing and enter the results of any study directly into issued formats as soon as it is finished and prepare the report immediately and get it checked by the second person preferably a senior person or head of the department.
5.14 Do not convey any result to any department verbally or telephonically, instead send the duly filled and checked report.
5.15 The data generated for all the study/calibration shall be submitted to the Archivist for archival.
5.16 The data shall be archived in the designated place.
5.17Carry out the calibration and validations of the instruments as per their schedule and update the schedule every time. Label the instrument after calibration.
6.0 ENCLOSURES
6.1 Nil
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
2.0 SCOPE
2.1 This SOP shall be applicable for the procedure to be followed for Good Documentation Practices (GDP) in the Department of Quality assurance (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head-QA
3.2 All personnel involved in writing any documents
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 All personnel shall use a blue ink ball pen for signature and other documentation. Do not use a red ink pen for recording purposes. Gel ink pen shall not be allowed for documentation and signature purpose.
5.2 The date shall be written as dd-mm-yyyy or dd/mm/yyyy unless otherwise specified in the individual SOP.
5.3 The time shall be written in 24 Hours format e.g. 01:25 pm shall be written as 13:25 Hrs.
5.4 Wherever signatures are applicable, the signatures shall be done the same in all documents. However, both initial and full signatures shall be acceptable.
5.5 If by mistake a wrong entry is made, cut the entry with a single line so that the wrong entry can be readable and write the correct entry with the sign. Do the correct entry just above or beside the wrong entry immediately. Do not use an eraser or whitener to correct any error.
5.6 If documents get damaged (by spillage or any other reason), always retain the original document and rewrite the data in the new record. Keep the original document along with rewritten document with QA approval.
5.7 If multiple options are given, cross out the option which is not required. For example, selection of result, Complies / Does not Comply.
5.8 Fill the entire column given in format or annexure, if some activity/operation not carried out then make a diagonal line from top left to bottom right.
5.9 Ensure that the blank formats and protocols, in which the results are to be entered, are issued by the QA department.
5.10 Prepare and use formats/protocol only as per their respective standard operating procedures.
5.11 Attach or preserve the filled formats/protocols in the respective reports and in turn preserve these reports in the dedicated file.
5.12 Enter the details in the respective logbooks/ registers as soon as that particular operation is done.
5.13 Fill the raw data sheet online while performing and enter the results of any study directly into issued formats as soon as it is finished and prepare the report immediately and get it checked by the second person preferably a senior person or head of the department.
5.14 Do not convey any result to any department verbally or telephonically, instead send the duly filled and checked report.
5.15 The data generated for all the study/calibration shall be submitted to the Archivist for archival.
5.16 The data shall be archived in the designated place.
5.17Carry out the calibration and validations of the instruments as per their schedule and update the schedule every time. Label the instrument after calibration.
6.0 ENCLOSURES
6.1 Nil
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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