SOP for Pharma Industry

Tuesday, 20 December 2016

Procedure for Log book preparation.

1.0	PURPOSE To lay down a procedure for the preparation of log book for equipment.
2.0	SCOPE This procedure is applicable to the all equipment situated in Compny name.
3.0	RESPONSIBILITY Officer Production /Officer QA
4.0	ACCOUNTABILITY Head Production/Head QA
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5. 6 5.7 5.8	All the equipment must have an individual log book. . All the activity done on equipment shall be recorded in log book. The log book contain operational, cleaning & Brea down/ maintenance record. The log book for any equipment shall be contain the following parameters: a) Equipment Name b) Equipment Identification Number. c) Department d) Location e) Date f) Name of the product g) Batch Number h) Mfg. date i) Exp.date j) B.Size k) Operational activity (Procedure time) l) Done by. m)Checked By n) Verified By o) Remarks The log shall be prepared in a register form as per the Annexure-I. Any break down in equipment must be recorded. The log book for break down contain the fallowing parameter- a) Date b)Details of break down c)Corrective action taken d) Rectified by e) Checked by f) Remarks The log book shall be in a register form as per annexure II. Maintain the records of all equipment as per log book.
6.0	REFERENCES SOP guideline by D.H. Shah

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	EQUIPMENT LOG BOOK	QA/039/F01-02
Annexure II	BREAK DOWN LOG BOOK	QA/039/F02-00

8.0

ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 3							Head Production (Tablet) Deptt.
Controlled office Copy No. 4							Head Production (Liquid) Deptt
Controlled office Copy No. 5							Head Production (External) Deptt
Controlled office Copy No. 6							Head Production (Soap) Deptt
Controlled office Copy No. 8							Head Store Dept.(Main Block)
Controlled office Copy No. 10							Head Engineering Dept.
Controlled office Copy No. 11							Head Store Dept.(External Block)
10.0		REVISION HISTORY
*S.No.*			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

Annexure II

BREK DOWN RECORD

Date	Datails of Break down	Corrective action taken	Rectified by (Eng.)	Checked By (Prod.)	Remark

Annexure I

EQUIPMENT LOG BOOK

EQUIPMENT NAME:

EQUIPMENT ID NO.:

DEPARTMENT:

LOCATION:

OPERATION RECORD

CLEANING RECORD

Date

Product Name

Batch No

Mfg Date

Exp.

Date

Batch Size

Start time

Completion Time

Operator

Checked By

Cleaning done

Cleaned by

Checked By

Verified By IPQA

Remark

From

Monday, 19 December 2016

Procedure for maintenance/servicing and verification/ calibration of Balances by external agency

1.0	PURPOSE To lay down a procedure for maintenance/servicing and verification/calibration of balances by external agency.
2.0	SCOPE This SOP is applicable for maintenance/servicing and verification/calibration of balances by external agency.
3.0	RESPONSIBILITY Departmental Head Concern Production, Store, Quality control
4.0	ACCOUNTABILITY Quality Assurance Manager.
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5.6 5.7	Annual maintenance contract for the balances in different areas of different makes shall be given to the External Agency for their Maintenance/ Servicing and Verification/ Calibration. This shall be done by the Purchase Department Annually. External Agency, engaged for the annual maintenance of the Electronic Balances shall make the necessary maintenance on the balances under contract and verify/ calibrate the balances at every one year interval. In case of any breakdown, concerned department shall intimate to purchase department for the repair & maintenance of the balances. In such case, after every repair, balance shall be verified/ calibrated against the known weight by the external agency. During the visit of the External Agency for maintenance/ servicing and verification/ calibration of the balances, the concerned department head shall arrange to get their balances verified/calibrated in the prescribed format as per provided in SOP XXX/SOP/QA/73 or as per concern Department SOP. All the balances shall be verified for the Eccentric Accuracy Check (at five locations i.e. all four corners & center) and for its working range by the pre-certified standard weights (rounded-off to the nearest denomination) as per details provide in XXX/SOP/QA/073 or as per concern Department SOP. After doing verification/ calibration the duly filled-in format, by the representative of the external agency and checked by the concerned department head, shall be submitted to QA -Head for final review of the maintenance and verification /calibration of the balances. Each department shall arrange to maintain the calibrated weights in their own areas and also their certification from Weight & Measurement Department annually through the purchase department. These weights shall also be used for the daily calibration of the balances in each area before commencing the weighing activity in each department.
6.0	REFERENCES Nil