SOP for preparation of Specification, STP and COA
This Document describes (Standard Operating procedure) SOP for preparation of Specification, STP and COA for Raw materials, packing materials, in process and Finished products.
SOP for preparation of Specification, STP and COA
I. Purpose & Scope:
- The purpose of this SOP for preparation of Specification, STP and COA for Raw materials, packing materials, In process and Finished products.
- This Standard operating procedure shall be applicable for preparation of Specification, STP and COA for Raw materials, packing materials, in process and Finished products.
II. Responsibilities:
• All Quality control personnel shall be responsible to follow and implement this SOP.
III: Introduction and Procedural Part:
Procedure for preparation of Specification, STP and COA :
Quality Control department shall prepare the below documents:
- Raw Material Specification.
- Raw Material Standard Testing Procedure.
- Packing Material Specification.
- Packing Material Standard Testing Procedure.
- In process product Specification.
- In process Product Standard Testing Procedure.
- Finished Product Specification.
- Finished Product Standard Testing Procedure.
- Specification/STP Index.
- COA of Raw Material, Packing Material, In-process & Finished Product
- General test procedures
Procedure for preparation of Specification:
- The Specification format for Raw Material, Packing Material, In process & Finished Product shall be as per given in Annexure-I.
- Whenever the specification is to be prepared according to pharmacopoeia grade, refer relevant current monograph.
- The following procedure is followed for In house grade.
- Specification shall be derived from Accelerated stability study or any other source.
- Annual product review
- Master batch formula for physical parameters
The Content (Text matter) during preparation of specification consists of the following.
Product Information:
- Formula (Molecular Formula, Structural Formula & CAs No.)
- Label Claim
- Retest Period
- Shelf life
- Artwork Number
- Pharmacopeial status
- Supplier/Manufacturer
- Sampling Procedure
- Sample & Control sample Quantity.
- Item Code
- Testing procedure
- Storage procedure
- Sampling and Handling Precautions (If Any)
Raw Material: A, C, F, G, H, I, J, K, L & M
Packing Material: E, G, H, I, J, K, L & M
In process: B, H, F, I, K, L & M
Finished Product: B, D, F, H, I, J, K, L & M
Summary of change:
- Details of the history of Specification i.e. the changes undergone since first issue of the Specification in ascending order.
- Maximum 3 revision shall be mentioned in summary of Change.
Standard Testing Procedure:
- The STP format for the Raw Material, Packing Material, in process, Finished Product shall be as per Annexure-II
- STP shall be prepared based on the test method given in pharmacopeia or from method Validation data.
- STP shall provide the method of the testing as per the respective specification.
- Write the test details along with GTP reference.
The content (text matter) of the STP consists of the following:
- Name of the Test.
- Reference of General test procedure and SOP (If any)
- Instrument/Equipment
- List of Reagent
- Procedure
Revision History:
- Details of the history of STP i.e. the changes undergone since first issue of the STP in ascending order.
General Test procedure :
- The General test procedures shall be prepared for Limit tests & chemical tests.
- The format for General test procedure shall be as per Annexure —
- General test procedure shall be revised when change in respective pharmacopoeia.
- General test procedures shall be numbered as GTP001. Where GTP stands for General test procedure and 001 stands for serial number.
- Reference chapter shall be defined in General test procedure.
Preparation of Specification/STP Numbering:
- Each Specification / STP shall have a unique number of alphanumeric systems as described below.
XNYYYY
Here,
“X” stands for Specification (S) & STP (T)
“N” stands for material description (Refer table No.1)
“YYYYY” stands for the serial number.
Example: SA0001
Here,
“S” Stands for specification
“A” Stands for Active Raw Material
“0001” Stands for the serial number of “specific material active raw material”
(As per Active Raw Material Index)
Example: TF0025
Here,
“T” Stands for STP
“F” Stands for Finished product (General)
“0025” Stands for the serial number of “specific finished product”
(As per Finished product Index General)
-
Material Description:
The code of material description shall be as given below
| Sr. No. | Material description | Code (N) |
| 1 | Active Raw Material (General) | A |
| 2 | Excipients | E |
| 3 | Packing Material (General Block) | p |
| 4 | In process Product | I |
| 5 | Finished Product (General) | F |
Version Number
The version number shall be given in sequence as given below;
| Sr. No. | Version | Number |
| 1 | First version | 00 |
| 2 | Second version | 01 |
| 3 | Third version | 02 |
- Once a number given to the Specification/STP will not change and cannot be assigned to any of new of Specification/STP in case that particular material is discontinued.
- The date from which the preparation of specification/STP will be implemented (Effective Date) should be typed in dd/mm/yyyy format
- The Review date which is 3 years from the effective date shall be written in dd/mm/yyyy format.
Document Approval:
- QC Department shall take one original set of print on A4 paper sheet and shall be signed as described below.
- The name of person who prepares the document shall sign in the “PREPARED BY” column.
- Executive or designee QC shall check the document and shall sign in the “CHECKED BY’’ Column.
- The name of Head QC /Designee who shall verify the document and shall sign in the first part of “APPROVED BY” column.
- Ensure the date shall be written with Day, Month and Year.
- Approved Specification & STP shall be handover to QA department for generation of Master copy & Controlled copy shall issue to Quality Control department.
- QA person shall assign the Effective date & Review date of document.
- QA Person shall generate the Master Copy of Specification & STP. From Master copy the controlled copy shall issue to Quality Control Department.
- Specification/STP index shall be prepared quarterly as per Annexure III.
Revision of STP / Specifications:
- preparation of Specification/STP shall be reviewed and revised for periodic revision after every 3
- years or as and when discontinued as per the current version of Change Control Procedure.
- In case of discontinuation of any document, the particular document number shall not be assigned to any other document.
- “Master Copy” of previous version shall be stamped as “OBSOLETE” on all the pages and archived in QA department.
- Controlled Copy” shall be retrieval before issuance of new copy by QA & shall destroy the same.
Preparation & Storage of COA:
- The COA shall be prepared and stored as mentioned in below path.
- Go to Network, double click on “Quality PC”. Then double click on “COA” click on individual product folder.
- The COA shall be copied and saved in respective folder. COA shall be prepared by putting the information/values from raw data and shall be saved.
- The Finished product COA shall be prepared for each batch based on the raw data Worksheet as per specimen format given in Annexure-IV.
- The COA of Finished Product shall be prepared by, checked by QC and released by QA
- Four copies of finished product COA shall be printed.
- Copy Number 01 shall be attached with Analytical report. Copy Number 02 shall be given to finished goods store. Copy Number 03 & 04 shall be given to marketing for dispatch.
- All other copies shall be distributed through Quality Assurance personnel.
- The product / Material name shall be written along with pharmacopeial reference which is applicable i.e. In-house /BP/EP/USP/JP etc. in brackets.
- The Raw material and Packing material COA shall be prepared for each batch based on the Raw Data worksheet as per the specimen format given in Annexure-V.
- The In-process product COA shall be prepared for each batch based on the raw Data worksheet as per the specimen format given in Annexure-VI
- The COA of Raw material, Packing material & in process shall be prepared, checked, by QC and Approved by QC Head.
- The print out of COA shall be taken on PDF copy of company letterheads.
IV: Annexure(s):
Annexure I: Raw/packing material/ in-process /finished product specification
Annexure II: Standard testing procedure
Annexure III: Specification/STP Index
Annexure IV: Finished Product COA
Annexure V: Raw material/Packing Material COA
Annexure VI: In process COA
Annexure –I
QUALITY CONTROL DEPARTMENT
Page No. 1 of 2
| RAW/PACKING MATERIAL/INPROCESS/FINISHED PRODUCT SPECIFICATION | |||
| Material/Product Name | |||
| Specification No. | Page No. | ||
| Version No. | Effective Date | ||
| Supersede No. | Review Date | ||
- PRODUCT INFORMATION
Annexure –I
QUALITY CONTROL DEPARTMENT
Page No. 2 of 2
| RAW/PACKING MATERIAL/INPROCESS/FINISHED PRODUCT SPECIFICATION | |||
| Material/Product Name | |||
| Specification No. | Page No. | ||
| Version No. | Effective Date | ||
| Supersede No. | Review Date | ||
- SPECIFICATION
| Sr.No. | Test | Specification | Reference |
III.REVISION HISTORY
| Version No. | Reason for Revision | Change control No. | Effective Date |
| SIGN & DATE | PREPARED BY | CHECKED BY | APPROVED BY |
| NAME & DESIGNATION |
Annexure –II
QUALITY CONTROL DEPARTMENT
Page No. 1 of 1
| RAW/PACKING MATERIAL/INPROCESS/FINISHED PRODUCT STP | |||
| Material/Product Name | |||
| STP No. | Page No. | ||
| Version No. | Effective Date | ||
| Supersede No. | Review Date | ||
| Ref. Spec. No. | |||
- TEST PROCEDURE :
- DESCRIPTION :
Follow the procedure as per the ___________________
Procedure: ___________________________
- ASSAY
Follow the procedure as per the ____________________
Instrument/Equipment: ___________________
Reagent:
1.
2.
Procedure: ____________________________________
- REVISION HISTORY
| Version No. | Reason for Revision | Change control No | Effective Date |
| SIGN & DATE | PREPARED BY | CHECKED BY | APPROVED BY |
| NAME & DESIGNATION |
Annexure –III
Active raw material / Excipients / Packing material / Semi finished product / Finished Product SPECIFICATION / STP INDEX Version No. Page No. of
| Sr. No. | Name of
Material/Product |
Specification
No. |
STP No. | Version No. | Effective Date | Review Date |
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| Prepared By | Checked By | Approved By | |
| Signature | |||
| Date |
ANNEXURE –IV
QUALITY CONTROL DEPARTMENT
| Name of the Product | |||
| Batch No. | Batch Size | ||
| A.R. No. | Sample Qty. | ||
| Mfg. Date | Packed Qty. | ||
| Exp. Date | Date of Sampling | ||
| Specification No.: | Date of Analysis | ||
| Copy Number | |||
| Sr.No. | TEST | SPECIFICATION | RESULT |
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Remark: The product complies / does not comply as per the USP/BP/EP/IP/In-house specification.
| Prepared By | Checked By | Released By QA | |
| Name | |||
| Signature | |||
| Date |
Annexure –V
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
| Name of Material | |||
| GRN No./Date | Qty. Received | ||
| Mfg. B. No. | Date of Sampling | ||
| A.R. No. | Date of Analysis | ||
| Mfg. Date | Retest Date | ||
| Exp. Date | Specification No. | ||
| Mfg./Supplier Name : | |||
| Sr.No.
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TEST | SPECIFICATION | RESULT |
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REMARK: The product complies / does not comply as per the USP/BP/EP/IP/In-house specification.
| Prepared By | Checked By | Approved By | |
| Name | |||
| Signature | |||
| Date |
ANNEXURE –VI
QUALITY CONTROL DEPARTMENT
| Name of the Product | |||
| Batch No. | Batch Size | ||
| A.R. No. | Sample Qty. | ||
| Mfg. Date | Date of Sampling | ||
| Exp. Date | Date of Analysis | ||
| Stage | Specification No.: | ||
| Sr. No. | TEST | SPECIFICATION | RESULT |
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Remark: The product complies / does not comply as per the USP/BP/EP/IP/Inhouse specification.
| Prepared By | Checked By | Released By | |
| Name | |||
| Signature | |||
| Date |
Annexure –VII
GENERAL TEST PROCEDURE
Page No. 1 of 1
| GTP Name | Page No. | ||
| GTP Number | Effective Date | ||
| Version Number | Review Date |
- PROCEDURE :
- Reference:
- REVISION HISTORY
| Version No. | Reason for Revision | Change control No | Effective Date |
| SIGN & DATE | PREPARED BY | CHECKED BY | APPROVED BY |
| NAME & DESIGNATION |
