Some Example Laboratory
Working Procedure
Author:
Someone Smith
Reviewed and Approved By:
__________________________________________________
DATE
1.0 Subject
Writing Standard Operating Procedures.
2.0 Purpose
The purpose of this procedure is to describe the steps and principles required to write and revise a standard operating procedures and associated forms.
3.0 Scope
The scope of this procedure applies to the cGMP PET Program in the Medical Department including the GMP operations in the radiochemistry laboratory.
4.0 Safety Concerns
Any particular concerns that are relevant to the subject procedure even if such items are covered in a general safety manual, Experimental Safety Reviews (ESR) or Radiological Work Permits (RWP).
5.0 Definitions
The definition of all terms that are crucial for the understanding and correct performance of the procedure need to be included.
6.0 Procedure
All procedure should be written according to the following instructions in order to be in compliance with GMP laboratory requirements. The standard font is Arial 12.
Headings with X.0 should be classified as Heading 1. Headings with X.X should be set to Heading 2 and Headings with X.X.X should be set to Heading 3.
6.1 Template
Use the SOP template when writing procedures to ensure that all procedures meet minimum standards.
6.2 Printing
Print all standard operating procedures on plain white 81/2 x 11 inch paper.
6.3 Header Information
3. Unique Procedure number assigned by Document Control made up of a letter and three numbers
4. Revision assigned by Document Control
5. Effective Date (DDMONXXXX) assigned by Document Control which is the date the SOP can be used
6. Page # of #
6.4 Procedure Body
Include the following information in the body of the procedure. If the section doesn’t require any information, the SOP preparer should insert “n/a”.
1.0 Subject 2.0 Purpose 3.0 Scope 4.0 Safety Concerns 5.0 Definitions 6.0 Procedure 7.0 References 8.0 Change History
6.5 Numbering
Number each section and subordinate headings decimally e.g. 6.0, 6.1, 6.1.1, 6.1.1.1, etc.
6.5.1 Spacing
Place two spaces after each number and before the heading text.
6.5.2 Section Separation
Enter a line before each X.X heading.
6.6 Procedure Inclusions
Include Safety Concerns, Notes, and Handling and Packaging Requirements
6.6.1 Safety
Include safety concerns if equipments relates to safety.
6.6.2 Packaging
Include special handling/packaging requirements.
6.6.3 Notes
6.7 Meaning of terms
Use certain verbs in these procedures which have the same meaning as their use in the cGMP regulation.
6.7.1 Mandatory requirements
“Must” or “Shall” indicate a mandatory requirement.
6.7.2 Desirable practice
“Should” or “May” indicate a desirable practice, but is not mandatory.
6.8 Footer Information
The footer should contain the phrase:
VERIFY IN DOCUMENT CONTROL THAT THE REVISION IN THE HEADER IS STILL THE CURRENT VERSION.
In Arial font 8
6.9 Issuance of SOPs and Forms
SOPs and associated forms should be written by a person competent and experienced to do so. It is accepted that the best person to write the SOP is the person who performs the procedure regularly. The Document Control Coordinator or designee will number and issue all SOPs and forms to the staff; and will also be responsible for organizing the annual review of SOPs and forms. The procedure for issuing SOPs (and forms) will be as follows:
• Each SOP/Form should be reviewed at draft stage by the staff that will use it to identify the issues addressed.
• The cGMP Coordinator or designee should review each SOP/Form.
• An electronic copy of the satisfactory draft SOP/Form should be provided to the Document Control Coordinator or designee. All other paper and electronic copies of the draft should be destroyed.
• The Document Control Coordinator or designee will assign the next lowest available sequential revision letter to the SOP/Form, and enter this letter in the header on each page. An addition to the revision history will be made indicating the change to the document.
• The names of the author and the approver will be entered on page 1.
Note: An approval and signature page is not requires for forms associated with an SOP.
• A master copy will be printed.
effective
• Training will be conducted on each SOP prior to the effective date. This training will be documented and the signed training record placed in each staff member’s training file.
• Deficiencies in SOPs/Forms should be recorded and reported to the Document Control Coordinator or designee, who will arrange for appropriate SOP’S/Forms prepared or existing ones modified to address these deficiencies.
6.10 Revision of SOPs/Forms
• All SOPs and associated forms should be reviewed annually by the Document Control Coordinator or designee and the staff members to suggest changes in the procedure.
• Minor changes to procedures which have no impact on the quality of the product will be incorporated at the annual review.
• Changes which have an impact on product quality will be introduced as soon as possible with an approved revision to the SOP/Form.
• A revised SOP/Form should replace an outdated SOP/Form within 30 days. • Hand-written or other alterations of an approved SOP/Form are not allowed.
6.11 Retrieval of SOPs/Forms
When an SOP/Form is superseded by a new SOP/Form, the following steps should be taken to replace the old SOP/Form version with the new approved version
• Copies of superseded SOPs/Forms will be collected by the Document Control Coordinator or designee.
• The master copy should be retained, but all other copies of the SOP/Form should be destroyed.
• The master copy should be stamped with the following stamp, the information filled out and the document placed in the archive file locked filing cabinet under the control of the Document Control Coordinator.
7.0 References
Cite any references to manuals, diagrams, etc. here
8.0 Change History (Examples provided to illustrate).
Changes must be documented in the Change History section of the SOP. This should include the date, the revision letter (A, B, C etc) and a description of the change. The header must reflect the change. The Document Control Coordinator will modify the electronic file accordingly and obtain reviewer signature. Prior to changes in the electronic copy of the SOP, changes and revisions can be entered in non-smearing pen in the current original SOP along with the initials and the date. Entry errors (ee) must be crossed out with a line and initialed and dated. All hand-written changes to any cGMP document must be accompanied by initials and date.
14MAY2008, Revision E, add information for forms associated with SOP’s 30APR2008, Revision D, insert stamp
19MAR2008, Revision C, replace the GMP with cGMP
12FEB2008, Revision B, provide detail in section 8 on how to implement changes to the SOP
