SOP on SOP in Pharmaceuticals for Formatting, Approval, Distribution & Retrival. This format is apply on all the Department SOP.
SOP on SOP in Pharmaceuticals
Sop on Sop is created by Quality Assurance Manager to improve the Quality of formating on Standard Operating Procedure and create a separate look in SOP.
1.1. The objective of this procedure is to lay down the procedure for the Preparation, Review, and Approval. Implementation, Distribution Retrieval and Control of Sop on Sop (Standard Operating Procedures).
2.1. The procedure applies to all departments of ____Pharmaceuticals for the preparation of Sop on Sop and Forms.
3.1. It is the responsibility of all ____Pharmaceuticals employees to follow this SOP as it is in written.
3.2. It is the responsibility of QA Manager to ensure that this SOP is followed in its entirety, review and update as necessary.
3.3. All the staff working at _____Pharmaceuticals must understand and trained, where appropriate, to this procedure and they shall follow SOPs pertaining to their area of work.
3.4. The approvals of the SOP on SOP in pharmaceuticals shall the contents with the cGMP and regulatory requirement whatever applicable.
DEFINITIONS & ABBREVIATIONS
4.1. ____: __________Pharmaceuticals Pakistan
4.2. QMS: Quality Management System
4.3. cGMP: Current Good Manufacturing Practices
4.4. QA: Quality Assurance
4.5. SOP: Standard Operating Procedure
4.6. CCR NO. Change Control Request Number
MATERIALS & EQUIPMENT
6.1.1. The SOP will be authored by representatives from the concerned department or any designated person and the contents agreed by the departmental head.
6.1.2. The nominated author will address comments and prepare the final draft document.
6.1.3. Write the SOP in short sentences. Avoid use of narrative language.
6.1.4. Do not use bullets.
6.1.5. Use the following font style and size while using the Microsoft Word for SOP / Policy writing.
22.214.171.124. Company Name: “Times New Roman”, size ’18’, upper case bold letters.
126.96.36.199. SOP Title: “Times New Roman”, size ’12’, upper case bold letters.
188.8.131.52. Main Headings: “Times New Roman”, size ’12’, upper case bold letters.
184.108.40.206. Sub-Headings: “Times New Roman”, size ’12’, First letter in upper case and rest in lower case of each word in bold letters.
220.127.116.11. Main Body: “Times New Roman”, size -12′, in sentence case, with single spacing.
6.1.6. Write main headings in upper case and bold letters and sub headings in lower case bold letters
6.1.7. Use “A4” size page.
6.2.1. Objective: An overview of the intent of the Sop on Sop shall be briefly mentioned here. This may include the purpose of procedure (why the procedure is prepared).
6.2.2. Scope: Define to which Department / Area Equipment / Procedure the Sop on Sop is applicable. This shall involve area of application of the procedure (where the procedure required to be performed).
6.2.3. Responsibility: Specify the personnel responsible to ensure the implementation and compliance (who performs the procedure, and who is responsible to see it is performed correctly).
6.2.4. Definitions & Abbreviations: Define the terms used in the procedure, list out all the abbreviations used in the SOP and their elaboration.
6.2.5. Materials & Equipments: Enlist the reagents, chemicals and equipments required to perform the task / process / operation.
18.104.22.168. There should be specific instructions for each step in sequential order including the preparatory work, which must be done before starting the main procedure, as well as instructions for recording and reporting the results.
22.214.171.124. Clear, concise and step-by-step instructions on how to perform the procedure. These content should written as per instructions of operator to follow, instead of a lot of theoretical background.
6.2.7. References: Mention the reference documents.
6.2.8. Required Documents: Enlist the documents required to complete the task, along with their SOP numbers.
6.2.9. Attached documents: Enlist the attached documents forms used for the records.
6.2.10. List of Recipients: Tabulate the recipients of this procedure; take signatures both on issuance and withdrawal.
6.2.11. Change History: Revision details are tabulated with the following information.
126.96.36.199. Version No.
188.8.131.52. Change Control Request No. (CCR No.)
184.108.40.206. Revision Details
6.3.1. The following information shall appear in the “Header” of SOP format:
220.127.116.11. GPL Logo (top left-hand side)
18.104.22.168. Company name (top, centered)
22.214.171.124. Relevant Department (2nd row, left column), give the name of the Originating Department (Example: Quality Assurance)
126.96.36.199. The document title (2nd row, right column), give the detailed heading specific to the operation of the SOP. (Example: Procedure for Preparation, Review, Approval, Implementation, Distribution, Retrieval and Control of Standard Operating Procedure)
188.8.131.52. SOP number (3rd row, left column), as described in 6.4
184.108.40.206. Page number (3rd row, right column), each page of the SOP shall have specific page number as well as the total number of pages the SOP comprises of. (Example: 1 of 10)
220.127.116.11. Approval Date (4th row left column)
18.104.22.168. Effective date (4th row. centre), the effective date is the date when the contents of the SOP become operative, alter training of the concerned personnel on the SOP.
Note: Sufficient time shall be allowed between approval date and effective date to facilitate training of the concerned personnel and to procure any required material as the case may be. In practice, 10 days except for special cases is considered sufficient as time period for training. The effective date shall be stamped / written with blue ink pen by QA representative when the training is complete and SOP becomes effective.
22.214.171.124. Review date (4th row, right column), all SOPs shall be reviewed within 3 years from the effective date. Review date shall be stamped / written in blue ink pen by QA representative.
126.96.36.199. Prepared by, Signature (5th row, left column), the personnel supervising the activity / operation, or who is directly involved in the procedure of the respective user department shall prepare the SOP and sign as “Prepared by” with date.
188.8.131.52. Reviewed by, Signature (5th row, centre column), the department head / functional head of the user department shall verify the adequacy of the procedure and shall sign in column as “Reviewed by” with date.
184.108.40.206. Approved by, Signature (5th row, 3rd column), all the SOPs of the site arc approved by Quality Assurance Manager and he shall sign as “Approved by” with date.
6.3.2. Header format for SOP is shown in Annexure: I
Assignment of SOP Numbers
6.4.1. Each SOP shall be assigned with a unique number. This number shall consist of nine characters as described below.
6.4.2. The first two characters are English alphabets “QD” denoting the Quality Document Number while third character is a digit, indicating the Quality Document Number.
6.4.3. While fourth character is “-“and fifth and sixth character are alphabets indicating originating Department code. The following are the codes assigned to the departments.
|Sop on Sop||Standard Operating Procedure|
6.4.4. The seventh character is “-” Dash.
6.4.5. The next three characters are serial number of the SOP starting from 001 in the sequential order within the department as guide in Sop on Sop.
6.5.1. Forms are used to record the data / results.
6.5.2. The header of the attached Forms contain the:
220.127.116.11. GPL’s Logo (1st row, 1st column)
18.104.22.168. Company Name (1st row, 2nd column)
22.214.171.124. Form Number (2nd row, 1st column)
126.96.36.199. Form Title (2nd row, 2nd column)
188.8.131.52. Reference Document No. ( 3rd row, 1st column)
184.108.40.206. Effective Date (3rd row, 2nd column)
220.127.116.11. Page — of – (3rd row, 3rd column)
6.5.3. Header format for Forms is shown in Annexure: I
6.5.4. Each Form shall be assigned with a unique number. This number shall consist of ten characters as described below.
6.5.5. The first character is English alphabet F represent the Form. The next two characters are English alphabets denoting the Originating Department code (as mentioned in 6.4.2).
6.5.6. The fourth character is “-” Dash.
6.5.7. The next three characters are serial number of the Form starting from 001 in the sequential order within the department.
6.5.8. The Eighth character is “-” Dash.
6.5.9. The last two characters denote the Revision Number of Form. The first time any Form is written, it shall be numbered as “00”. The first revision of Form shall be “01” and so on.
6.5.10. QA department will assign the Document Number and maintain a log book for these numbers.
For Example: The First Form prepared as per this procedure for Quality Assurance Department shall be numbered as “FQA-001-00” and same when revised for the first time shall be numbered as “FQA-001-01”.
6.6.1. The author sends a soft copy of the SOP to the department head or designee for review of the contents.
6.6.2. After review, the department head forwards the SOP to QA.
6.6.3. QA review the contents with reference to format and technical aspects.
6.6.4. QA keeps the finalized son copy in PDF format.
6.6.5. Print out the final document on A4 size white paper and circulate to the author and identified approvers for approval signatures.
6.6.6. The approval date will be the date of the final approval signature.
6.6.7. The effective date may be up to 10 working days from the date of approval to provide a window for training and compliance to the document.
6.6.8. Where urgently required a SOP / Policy may be issued as approved and immediately effective, but making sure that at the time of the effective date:
18.104.22.168. The SOP should be read and understood by impacted site and functional group heads as relevant to the Sop on Sop / Policy.
22.214.171.124. Appropriate Standard Operating Procedures should be in place as relevant to the work station.
6.6.9. Only QA Manager or designee has the access to “Master Document File”.
6.6.10. Keep the obsolete documents in a separate folder labeled as “Obsolete Document File” in QA department.
6.6.11. Such copies shall be archived by QA department along with the respective change control. In such case follow the document change control initiation as per Sop on Sop (Title: Change Control).
6.6.12. Keep one copy of last obsolete version for record.
9.1. Annexure I _- Format of Header of SOP’s and Forms
Header Style of SOPs
|Department Name||TITLE OF SOP|
|Document No:||Page: __ 0f __|
|Approval Date:||Effective Date:||Review Date:|
|Prepared by||Reviewed by||Approved by|
Header Style of Forms
|Department Name||TITLE OF Form|
|Document No:||Page: __ 0f __|