XXX Sciences Division
SOP Code / XXX/SOP/001 / Issue No / 05 / No of pages / 11 / Manual No.ISSUE No. / Revision History / Author / Effective Date
01 / New Procedure / 24 April 03
05 / Changes toSOP header and footer to reflect new University logo and re- branding (see also within sections 5 & .6). 3 Update of responsibilities.
4.0 Update of Related Documents
7 major changes to storage and archiving
8-11 change to paragraph numbering not content
NAME (print) / SIGNATURE / DATE
WRITTEN BY:
APPROVED BY:
REVIEWED BY:
QA
EFFECTIVE DATE: / REVIEW DATE:
Full Revision History
ISSUE No. / Revision History / Author / Effective Date01 / New Procedure / 24 April 03
02 / 5.3 Addition of other Controlled Document types
5.4 and 5.5 Header and Footer updates.
5.10-5.12 Updating of review/Q Pulse
6.1 Colour Date Stamp
6.6 Q Pulse electronic copies
6.7 2 year default review date
7.0 General updating including Archived SOP manual/Q Pulse/ other controlled document types / 29 April 04
03 / Cover Page and 5.7 Extension of history from cover page to page 2 if space limited.
5.11/ 5.12 / 6.6 using Q Pulse to update and review documents
6.8 and 6.9 Procedures when after review of SOPs no changes are needed to SOP and associated Form. / 6 April 05
04 / List of current users section to include use training requirements in new SOPs. Update of related documents.5.3 Additional controlled documents. 6.3 SOPs on YYYY 7.1 Storage of pre archived SOPs 7.2 Retention of superseded documents. 7.5 Electronic copies / 24 March 06
05 / Changes to SOP header and footer to reflect new University logo and re- branding (see also within sections 5 & .6). 3 Update of responsibilities.
4.0 Update of Related Documents
7 major changes to storage and archiving
8-11 change to paragraph numbering not content
1INTRODUCTION The purpose of this SOP is:
1. 1To define the procedure by which Standard Operating Procedures (SOPs), and similar Controlled Documents, for the Xxx Sciences Division Cityname are prepared, revised, issued, and controlled.
1.2 To define the format and content required for SOPs and Controlled Documentation.
1.3 To describe the system used to approve issue and revise SOPs.
1.4 To describe the procedures used to archive old versions of Controlled Documents and issue of current versions of SOPs to appropriate manuals.
2SCOPE
2.1 This SOP applies to all documents used to control the management and processes associated with clinical trials within the Xxx Sciences Division Cityname.
3RESPONSIBILITIES
3.1All staff responsible for writing and approving Controlled Documents must ensure they conform to the format and content as outlined in this SOP.
3.2Departmental Managers are responsible for the timely production, revision and approval of SOPs and other forms of controlled documents applicable to their areas.
3.3Management are responsible for ensuring that their staff are trained and comply with the requirements of all SOPs and must notify QA if a delay for training of staff will be required post SOP management review. (most departments and work areas in ABC are small and staff involved with, but not actually formally writing, the SOP update will have been asked by their co workers for input)
3.4The Document Controller is responsible for managing the issue, revision, approval, distribution, removing and pre archiving of the controlled documentation.
3.5Quality Assurance is responsible for ensuring SOPs under this document control system are prepared reviewed revised approved and issued according to this SOP.
3.6 All staff have a responsibility to be familiar with SOPs that apply to their work, and to request SOP updates (possibly via change control procedures) when procedures may need to be updated before the 2 yearly default review
3.7The archivist is responsible for all aspects of archived controlled documents
4RELATED DOCUMENTS
External
4.1European Union’s Clinical Trials Directive. EU Directive (2001/20/EC)
4.2Medicines for Human Use (Clinical Trials) Regulations 2004. SI 2004. 1031
4.3EU Directive 2005/28/EC Detailed Guidelines for GCP with regards to Investigational Medicinal Products
4.4EU Directive 2003/94/EC Principles and Guidelines of GMP in respect of Medicinal Products for Human use and IMPs for Human use.
4.5Medicines for Human Use (Clinical Trials) Amendment 2006. SI 2006 1928
4.6The ICH Guidelines for Good Clinical Practice. Jan 1999/CPMP/ICH/135/95
4.7European Commission Volume 4 Good Manufacturing Practices ANNEX 13
4.8Rules and Guidance for Pharmaceutical Manufacturers and Distributors2007 (The Orange Guide)
4.92004/23/EC European Union ‘Parent Directive’ on Setting standards of Quality and safety for the Donation Procurement Testing and processing Storage and distribution of Human Tissues and Cells
4.10Human Tissue Act 2004
Internal
4.11Cityname University MHRA MIA (IMP) 12345 (replacing MA ( IMP)12345)
4.12University of CitynameXxx Sciences Division HTA Licence 12345
4.13ABC/FORMS/001 SOP Amendment Form
4.14ABC/FORMS/002 Document Archives Form
4.15ABC/FORMS/003 Record of Revisions Form
4.16 ABC/FORMS/200 SOP Review Form No Changes
4.17 ABC/FLOW/001 Document Control Flow Chart
4.18ABC/SOP/231 Data Protection Procedures
4.19ABC/SOP/238 Document Control of Electronic SOPs
4.20ABC/SOP/232Policies and Overview of Archiving Procedures
4.21ABC/SOP/233Preparation and Receipt of Items to be Archived
4.22ABC/SOP/002 Approvals Procedures for Chemicals and Materials).
5PROCEDURE FOR WRITING AND APPROVING SOPs and Other Controlled Documents
5.1A basic SOP template can be obtained from the Document Controller. The Title Page Format and content of this template is mandatory.
5.2All Controlled Documents have an individual number and issue number, which will be issued by the Document Controller.
5.3The numbers will have a different prefix depending on the type of document as follows:
ABCXxx Sciences Division Cityname
SOP for Standard Operating Procedure
PMR for Product Manufacturing Record
FORMS for Forms
FLOW for Flowcharts
URS/IQ/OQ/SEC for validation qualification documents.
DCA for Deviations and Corrective Actions
OOS for Out of Specification
VMP/VREP for Validation Plans and Validation Reports
001 is the SOP (or FORM/PMR etc) number
01 this represents version or issue number (in this case 1).
5.4The Header or Footer of all controlled documents will contain the document identifying number and version ( in the case of Controlled Documents originating from FORMS, the corresponding original FORM number and issue number will also be included in brackets) and also have page number and total number of pages.
5.5SOPs.
All SOPs should be written in Microsoft Word using the Arial 12pt. font. Tables, charts or worksheets should be in an appropriately clear format.
5.6All SOPs should comprise of a
TITLE PAGE. This will be formatted as four boxes or tables (in addition to the page headers and footers) as follows.
- The Full Title (in Arial 18 bold).
- The SOP code/ issue number /draft number of pages/manual number.
- History of changes made to previous versions of the procedure with effective dates. If there is insufficient space for full history on the cover page, the original version and most recent update should be included on cover page and the full history table must be provided on page 2
- The printed name and dated signature of the document preparer/modifier. The printed names and dated signatures of approvers and reviewers. The effective date of the document and date for review (if no changes are made beforehand).
Following this page all SOPs should continue with the following sections, (overspill on history from title page is not section number) additional sections may be added if required by the author.
1. INTRODUCTION. A brief statement providing objectives or background of the document
2.SCOPE. Astatement of the areas to which the document applies.
3. RESPONSIBILITIES. An indication of those responsible for major tasks or the main responsibilities of particular individuals as appropriate.
4. RELATED DOCUMENTS. This may include forms or process sheets (which are controlled documents) related to SOPs/PMRs, (version numbers of related documents are not included); external documents covering directives/best practice and legislation
- PROCEDURE A statement of specific equipment, apparatus, chemicals and materials required, details of the methods employed and records kept. Specific health and safety requirements should also be included.
- APPENDICES. This section lists appended documentation which may include associated ABC Forms/external forms/ flowcharts/examples or lists to check or consider.
- LIST OF CURRENT USERS. All controlled documents shall have a page confirming people who have read, understood and are currently using the procedure in ABCand the training requirements associated with the update.
5.7The header of all controlled SOP documents will contain the document title (which may be abbreviated) the footer will remind users that ‘ONLY CONTROLLED COPIES (COLOUR DATE STAMPED) TO BE USED FOR PROCEDURES’
5.8Draft SOPs/other Controlled Documents may be prepared by any member of the department. Generally, they are best written by the main person who will use the document.
5.9Any amendment to a controlled document however minor requires a new version of the
document to be produced. Annotation of SOPs held in manuals is not permitted.
5.10The Document Controller will assign an appropriate document number for new SOPs.
5.11If a current SOP is to be reviewed the Document Controller will provide a copy of the current version of the SOP in the Q Pulse ‘Draft Directory’ for authors and reviewers to change review and approve the SOP within Q Pulse (this version is ‘tracked changes’ rather than ‘read only’).
5.12If Q Pulse review is not practicable for any reason (e.g. where authors or reviewers are not based within ABC computer network, or do not have access to Q pulse; or where there is a ‘major rewrite’ rather than amendment), authors and reviewers may use hard copies to update or with agreement of Document Control may start with a brand new document.
5.13The review process should include specifications of suitable chemicals and materials (and note that approval of the supplier and chemical/material may be necessary before commencing a project see ABC/SOP/002 Approvals Procedures for Chemicals and Materials).
5.14If the draft could not be simply approved/ amended by all reviewers, a meeting should be held to resolve differences and to provide the final version for the Document Controller.
5.15The Document Controller will incorporate final amendments and issue the Master Copy of the document on white paper for signatures. The author signs and dates the prepared section followed by the reviewers (usually the appropriate manager).
5.16Approved documents are then given to the Quality Assurance who signs the document when satisfied that the approval process has been satisfactorily completed and is the final authorising signature
5.17Non-approved changes with their reasons for no change will also be filed by the document controller for future reference (on ABC/FORMS/001 back page)
6.0ISSUE AND DISTRIBUTION OF CONTROLLED SOP DOCUMENTS
6.1The Document Controller is responsible for the issue of the controlled documents. All controlled documents will be colour stamped ‘Controlled Copy’ with the date they were issued.
6.2An electronic version of SOPs is held by the Document Controller, but the original signed paper copy in the Standard Operating Manual is the MASTER document. (See also 6.6)
6.3Most users of specific SOPs/PMRs must sign the original copy of the MASTER document SOP/PMR sheet to confirm they have read and understood the procedure, and it’s changes if a new version(note the mmm CRU & external CRN users are under a different signature procedure)
6.4ABC/SOP/238 Document Control of Electronic SOPs covers issue and update of web held SOPs see also 7.5
6.5The documents shall be issued to the areas as indicated on the Standard Operating Manual Index (Record of Revisions FORM 003).
6.6When a new version of a controlled document is being issued the old versions of the document must be removed and destroyed from the location and replaced with the new version; however the original MASTER is archived see 7.0
6.7Document Control will update Q Pulse records with new live issues of SOPs or other documents (but see following paragraph and section 8 regarding their status)
6.8Additional copies of uncontrolled documents can be made providing that the words UNCONTROLLED COPY appear on every page of the document. An electronic copy of some controlled documents (mainly for SOPs and FORMS) is held within the Departmental Q Pulse system. This is for general information only in the case of SOPs with each page watermarked with ‘UNCONTROLLED Q PULSE COPY’
6.9SOPs should be reviewed every 2 years form date of issue. It does not change the requirement outlined in 5.9.
6.10If SOPs are reviewed and no changes are deemed necessary the SOP review no changes form (ABC/FORMS/200; APPENDIX V) should be completed; ideally the signatures will be the original author(s) and reviewer(s).
6.11Document Control will affix the original completed form to the front of the MASTER SOP and copies to all controlled SOPs and the original SOP Amendment form.
7.0STORAGE AND ARCHIVING OF CONTROLLED SOP DOCUMENTS
7.1The Original Copy of all Controlled SOP Documents that have been superseded will be kept in a hard copy format together with the SOP amendment form ABC/FORMS/001. The location of archived documents and issue dates must be logged on the document archive sheet ABC/FORMS/002 which is kept in the Archived Standard Operating Procedures Manual which is strictly a pre archive storage location.
7.2Formal archiving of controlled documents is under ABC/SOP/233 Preparation and Receipt of Items to be Archived
7.3For some clinical trials the archived SOP will need to be stored with the Clinical Trial archived material -this will be clearly stated on ABC/FORMS/002.
7.4The length of the time the document is kept depends on the type of document: No controlled document may be disposed of without written authorisation from the Director of the Medical Unit. Refer to ABC/SOP/232 Policies and Overview of Archiving Procedures
7.5The Standard Operating Procedures Manual contains original approved MASTERS of theSOP/PMRs and an index (ABC/FORMS/003) that details all the CURRENT SOP/PMR titles, date of issue, issue numbers, revision date, number of copies and location of the SOP's.
7.6All FORMS used in the Quality System are controlled documents with a unique referencecode. All the FORMS are referenced in the appropriate SOP (and normally appended) to allow full traceabilitywithin the quality system.
7.7Update or revision of FORMs does not generally trigger and SOP update unless a procedure changed. For GMP production SOPs a FORM change will always trigger an SOP update to ensure adequate review and approval of changes by sponsor.
7.8Q Pulse is used for the storage and inventory of FORMS.
8Electronic Copies
8.1 Q Pulse is currently able to store details of all current and ‘archived’ SOPs. (see also 6.7) This is available for quick review/general information only as the hard paper signed copy of the MASTER is the original document (whether live or archived)
8.2YYYY/ZZZZ/other electronic versions. Staff in the Research Network (not based in Xxx Sciences Division Cityname) may view current SOPs in pdf form ‘in the field’ via YYYY. The document is marked “DO NOT PRINT – Electronic Copy. Only Current on Day of Viewing” . The electronic document is a controlled copy (covered by ABC/SOP/238), printed versions are for information only and not controlled
9OTHER CONTROLLED DOCUMENT TYPES
Although the main form of Controlled Documentation covered by this SOP is for ‘SOPs and their FORMS’; many other SOPs use a series of FORMS which give rise to other Controlled Documents which will also have a unique Document Control number. Details of these procedures are covered by their specific SOPs but for information include, (note this is not an exhaustive list), the various ‘Validation and Qualification’ Procedures; Deviation and Corrective Action Procedures; the Product Specifications, Process Sheets and Product Release Forms generated for each production batch.
10Appended
Appendix IABC/FORMS/001 SOP Amendment Form
Appendix IIABC/FORMS/002 Document Archives Form
Appendix IIIABC/FORMS/003 Record of Revisions Form
Appendix IVABC/FLOW/001 Document Control Flow Chart
Appendix VABC/FORMS/200 SOP Review Form No Changes
11 LIST OF CURRENT USERS and TRAINING.
Level of training required for update.
Read. Demonstrate/Briefing. Full Training
The Following people have been trained /read and understood this SOP and are currently using these procedures.
NameSignature Date
ONLY CONTROLLED COPIES (COLOUR DATE STAMPED) TO BE USED FOR PROCEDURES
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