sop for Preparation of Master Lists
1.0 PURPOSE
To provide the procedure for preparation of master list.
2.0 SCOPE
2.1 This SOP is applicable for preparation of master list for Standard operating Procedure, Equipment’s, Accessories,
Instruments, Departmental Staff, FDA Approved Competent Technical staff, Product, Drain Points, Sampling Points of
Potable Water, Purified Water, Compressed Air, Boiler Steam, Authorized Persons for Entry into Restricted Area,
Standard test Specifications, Standard test Procedures, General test Procedures, Process validation
cum report, BMR, BPR, MFR and Approved vendor, list of area coding at
3.0 References
3.1 In-house
3.2 Attachments
3.2.1 Attachment- 1 :Index of Standard operating Procedure
3.2.2 Attachment- 2 : Amendment to Index of Standard operating Procedure
3.2.3 Attachment- 3 : List of Equipment’s /Accessories/Instruments
3.2.4 Attachment-4 : Amendment to List of Equipment’s /Accessories/Instruments
3.2.5 Attachment-5 : List of Departmental Staff
3.2.6 Attachment- 6 : Amendment to List of Departmental Staff
3.2.7 Attachment- 7 : List of FDA Approved Competent Technical staff
3.2.8 Attachment- 8 : Amendment to List of FDA Approved Competent Technical staff
3.2.9 Attachment- 9 : List of Products
3.2.10 Attachment- 10 : Amendment List of Products
3.2.11 Attachment- 11 : List of Drain Points/Sampling Points of Potable Water/Purified Water/Compressed Air
/Boiler Steam.
3.2.12 Attachment- 12 : Amendment to List of Drain Points/Sampling Points of Potable Water/Purified Water/ Compressed Air/Boiler Steam.
3.2.13 Attachment- 13 : List of Authorised Persons for Entry into Restricted Area.
3.2.14 Attachment- 14 : Amendment to List of Authorised Persons for Entry into Restricted Area.
3.2.15 Attachment- 15 : List of Standard test Specifications (STS)
3.2.16 Attachment- 16 : Amendment to List of Standard test Specifications (STS)
3.2.17 Attachment- 17 : List of Standard test Procedures (STP)
3.2.18 Attachment- 18 : Amendment to List of Standard test Procedures (STP)
3.2.19 Attachment- 19 : List of General test Procedures (GTP)
3.2.20 Attachment- 20 : Amendment to List of General test Procedures (GTP)
3.2.21 Attachment- 21 : List of Process Validation Protocol cum Report
3.2.22 Attachment- 22 : Amendment to List of Process Validation Protocol cum Report
3.2.23 Attachment- 23 : List of BMR/ BPR/ MFR
3.2.24 Attachment- 24 : Amendment to List of BMR/ BPR/ MFR
3.2.25 Attachment- 25 : List of Approved Vendor
3.2.26 Attachment- 26 : Amendment to List of Approved Vendor
3.2.27 Attachment- 27 : List of Area Coding
4.0 Abbreviations
4.1 QA: Quality Assurance
4.2 FG: Finished Goods
4.3 QC: Quality Control
4.4 STS: Standard Test Specification
4.5 STP: Standard Test Procedure
4.6 GTP: General Test Procedure
4.7 SOP: Standard Operating Procedure
5.0 RESPONSIBILITY:
5.1 User Department/ QA Department:
5.1.1 To prepare required master list.
5.2 Concerned Department Head:
5.2.1 To review the respective master list prepared by concerned department person.
5.3 Quality Assurance:
5.3.1 To review the applicable master list.
5.4 QA Head:
5.4.1 To approve the master lists.
5.4.2 To ensure implementation of the defined procedure.
5.5 Plant Head:
5.5.1 To authorize the applicable master list.
5.5.2 To ensure implementation of the defined procedure.
6.0 Distribution
I. Quality Assurance
II. Quality Control
III. Production
IV. Ware house
V. Engineering
VI. Human resource and Administration.
VII. Environment, Health and Safety
7.0 PROCEDURE:
7.1 Prepare index of Standard operating Procedure as per Attachment-1.
7.2 Prepare Amendment to index of Standard operating Procedure as per Attachment- 2.
7.3 Prepare list of Equipment’s/ Accessories / Instruments as per Attachment-3
7.4 Prepare Amendment to list of Equipment’s/ Accessories / Instruments as per Attachment-4
7.5 Prepare List of Departmental Staff as per Attachment-5
7.6 Prepare Amendment to list of Departmental Staff as per Attachment-6
7.7 Prepare list of FDA Approved Competent Technical Staff as per Attachment-7
7.8 Prepare Amendment to list of FDA Approved Competent Technical Staff as per Attachment-8
7.9 Prepare list of Products as per Attachment-9
7.10 Prepare Amendment to list of Products as per Attachment-10
7.11 Prepare list of Drain Points / Sampling Points of Potable Water / Purified Water / Compressed Air / Boiler Steamas per Attachment- 11
7.12 Prepare Amendment to list of Drain Points / Sampling Points of Potable Water / Purified Water / Compressed Air / Boiler Steamas per Attachment- 12
7.13 Prepare list of Authorised Persons for Entry into Restricted Areaas per Attachment-13
7.14 Prepare Amendment to list of Authorised Persons for Entry into Restricted Areaas per Attachment-14
7.15 Prepare list of Standard Test Specification (STS) as per Attachment- 15.
7.16 Prepare Amendment to list of Standard Test Specification (STS) as per Attachment- 16
7.17 Prepare list of Standard Test Procedures (STP) as per Attachment- 17
7.18 Prepare Amendment to list of Standard Test Procedures (STP) as per Attachment- 18
7.19 Prepare list of General Test Procedures (GTP) as per Attachment- 19
7.20 Prepare Amendment to list of General Test Procedures (GTP) as per Attachment- 20
7.21 Prepare list of Process validation protocol cum report as per Attachment- 21
7.22 Prepare Amendment to list of Process validation protocol cum report as per Attachment- 22.
7.23 Prepare list of BMR/BPR/MFR as per Attachment- 23.
7.24 Prepare Amendment to list of BMR/BPR/MFR as per Attachment- 24
7.25 Prepare list of Approved Vendor as per Attachment- 25
7.26 Prepare Amendment to list of Approved Vendor as per Attachment- 26
7.27 Prepare list of area coding as per Attachment- 27
7.28 All Master lists shall be revised as and when required or every six months interval if any changes are to be made based
on amendment list. Revision is not required in case if there are no any changes / updates to be made in the Master list.
7.29 If there are any updates to be made in the master list within the six month interval period from date of approval of
Master list then the updates such as addition/ deletion/ changes are to be updated in the respective amendment list.
The updates made in the amendment list are to be updated in the Master list during the six monthly revision of Master list.
8.0 REVISION HISTORY
| Version No. | 00 | Effective Date | ——- |
| Details of revision: New SOP Prepared | |||