Rounding Off And Creation Of Data Records

1.0              OBJECTIVE:

To describe the procedure to write, fill and round off quantity in the documents.

2.0              SCOPE:

This SOP is applicable to all the people working in ---------------------------

3.0              RESPONSIBILITY:

The responsibility for follow the SOP lies with all concerned department designee/officer and Heads.

QA designee/officer responsibility for complies of the SOP.

4.0              ACCOUNTABILITY:                       

The Accountability of the SOP is of concerned department heads and Quality Assurance Head.

5.0              PROCEDURE:          

5.1              Personnel performing various operations shall create records in the forms designed for the purpose, at the time of carrying out the activity in clear legible wordings and shall confirm the entry by adding their initials or signature.

5.2              If an error is made in the record it shall be corrected as per GDP SOP No. SOP-QA-014, in such a manner that the original entry is not lost and corrections are initiated and dated.        

5.3              If the information asked for in the record is not applicable to the activity performed. The words ‘NA’ shall be written against each such instruction. No lines shall be drawn either across the printed matter or in the space provided for data entry for this purpose.

5.4              In accordance with cGMP requirements all batch production and control records and laboratory records shall be reviewed by a second person (supervisor or checker) for accuracy, completeness and compliance with established standards. If any discrepancies are found in the review, they shall be investigated using an Incident Report as per SOP No. SOP-QA-035. The investigation shall include, review of the raw data, reference documents etc. After satisfactory review, necessary corrections shall be made to the records. An additional sheet with the corrections shall be attached to the original records, if necessary. The corrections shall be countersigned by the checker/supervisor in the current date. Training shall be imparted to the concerned persons, if the investigations revealed the need for training, as per Training of Personnel.

5.5              If a record is spoiled, damaged and is not presentable/legible, an Incident Report as per SOP No. SOP-QA-012 shall be filled and a request for new forms shall be made. A new record shall be created using freshly issued forms in the Annexure no.: A/QA-019-01. Such forms shall be issued by the approving authority after confirming proper justification for issue and by making an entry in current date in the Issue Register. The new record shall indicate the date of creation and shall be filed along with the spoiled record. E.g. Pages of Batch Manufacturing Record (BMR), Analytical Work Record (AWR).

5.6              All the records/formats should be requisite by the concerned dept. The records/formats shall be filed as soon as they are completed, reviewed and signed.

5.7              Rounding off the Quantity:

5.7.1        If the quantity of ingredient calculated for the batch is having more than three digits after the decimal, then the quantity should be rounded off to third digit by considering the fourth digit.

5.7.2        Quantities given in BMR for a batch up to three decimal place and balance shows only up to two decimal, it should be write as shown on display of the balance.

5.7.3        Quantities In determining compliance with a numerical limit in an BMR & Analytical work record, the quantity / result should be calculated to one decimal place more than the significant figures stated and then rounded up or down as follows: if the last figure calculated / written is 5 to 9, the preceding figure is increased by 1; if it is 4 or less, the preceding figure is left unchanged e.g. 24.358 Kg round up 24.36 Kg & 24. 354 Kg round up 24.35 Kg.

5.7.4        If the ingredient is weighed on balance having display two digits after decimal point and least count of 10 g, then the third digit should be rounded off to the next number  e.g. If the quantity is 45.488 kg then it should be rounded off to 45.49 kg and if quantity is 45.483 kg. Then it should be rounded off to 45.48 kg.

5.7.5        For solvents the quantity to be rounded off to 2 digits after the decimal as per above procedure considering the third digit.

Note:

v   Rounding off the quantity is subject to the least count of the balance used.

v   The sum of the quantities of the raw materials after rounding off should be exactly equal to the total theoretical quantity of the batch.

v   If active strength is in microgram then rounding off should not be done and batch size in kg can be rounded off to second digit after decimal.

5.8              CONTROL OF DATA IN COMPUTER:

5.8.1        Any instruction / information / data stored in computer hard disc or soft copies (electronic copy) of such documents shall not be considered as official for regulatory purposes. The printed copies, which are signed and distributed in accordance with the instructions, shall be considered as official documents.

5.8.2        Product and operation related electronic data such as issue of a batch formula and instructions for batch manufacturing, specifications for testing, indents of materials; price information etc. shall have limited access control by providing password.

5.8.3        Backup data shall be stored in hard disk as well as in CD’s as appropriate by the document controller.

5.8.4        Soft copies of the master documents shall have limited access (only by Document controller) and issuance of such soft copies to other department shall be only on the approval by the Q. A. Head.

5.17Acceptance criteria

5.17.1    Records should be clear, legible & correct.

5.17.2    Frequency: Whenever required.

6.0              LIST OF ANNEXURE AND FORMATS:                            

Sr. No.	Title of Format	Format No.
01	Spoiled, Damaged Page Change Requisition.	F/QA-019-01

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-012

7.4              SOP-QA-014

7.5              SOP-QA-035

8.0              REVISION HISTORY:  

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

9.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
01	SOP	Standard operating procedure
02	CD	Compacted disk
03	QA	Quality assurance
04	cGMP	Current Good Manufacturing Practice

 

END OF DOCUMENT

Put trick mark if Applicable (ü)

Product / Equipment / Instrument				ID/Batch No.:
Product Name		Document No.		No of Pages Required		Remark
1.      Justification:
2.      Training Record Updated:	Yes                      No				Last Training Date:
3.      Incident Report (If Applicable):
Requested By Name:			Sign & Date:

CHECKED BY/ON (Originating Dept. HOD Sign/Date )
VERIFIED BY/ON (  Quality Assurance HOD Sign/Date)
Authorized  BY/ON (Plant Head Sign/Date)