Signatures and Dates

Standard for Preparation and Maintenance of SOP

Non-Smile Contributor
Author:
Kericho / Document Number: / Doc00-05
Effective (or Post) Date: / 6-March-09
Document Origin / Company: / Kericho
SMILE Approved by: / Jo Shim
Review by / Heidi Hanes / Review date / 9-Feb-12
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
SOP Title: Standard for Preparation and
Maintenance of SOP / SOP No: KEL 129
Version .1.
Effective Date: June 2007 / Page 1 of 10

Signatures and Dates:

Author: ______

RUKIA KIBAYA Deputy Lab. Director Date

QA Review: ______Date

Approving Authority: ______Lab. Director Date

Review/Approval for unchanged documents

DATE / Author / QA Review / Approving Authority

Purpose/Applicability:

1.1.  This SOP describes the preparation, implementation and maintenance of all SOPs in the KEMRI/WRP-CRC laboratory.

(a)  These standards are to ensure compliance with DOD, USMHRP regulations and GCLP requirements as appropriate for all investigational trials conducted at this trial site.

(b)  The Walter Reed Army Institute of Research SOP has been used as a guideline in the preparation of this SOP.

(c)  This SOP also describes procedures for SOP training and documentation of training.

1.2.  The designated Quality Assurance/ Quality Control (QA/QC) personnel, Laboratory personnel and the laboratory director or designee

1.3.  It is the responsibility of the laboratory director or designee to review and approve all SOPs. It is the responsibility of all staff to follow the SOPs that impact the research and clinical activities they perform. Technical staff is responsible for the preparation, review and updating of all SOPs relative to their daily operations. The lab director or designee(s) are responsible for ensuring that all SOPs are updated annually to meet the standards outlined within this SOP. Training on SOPs will be conducted upon entry into any position within CRC laboratory and annually for all personnel to which the SOP applies.

2.  Responsibilities:

2.1.  Laboratory supervisor/designee and all laboratory staff must make sure that the SOP is implemented and utilize as written

2.2.  Laboratory Supervisor/designee is responsible for reviewing, signing and dating all validated reports.

2.3.  Laboratory Director or designee is responsible for changes made on this SOP

3.  Materials and Equipments: N/A

4.  Procedures:

4.1.  All SOPs will meet the following standards:

4.1.1  Serve as a tool for staff either as reference material or procedural standards.

4.1.2.  Be easily understood by all technicians or personnel who may be responsible for the execution of the procedure.

4.1.3.  Be easily understood for training of new personnel, to ensure that the new personnel are capable of following the instructions.

4.1.4.  Be maintained within the SOP’s applicable sections.

4.1.5.  Follow the WRAIR SOP format as an example, including the header and page numbers. The CRC lab SOP does not carry the header in all the pages except the front page but the information is carried in the footer.

4.1.6.  Have an assigned SOP number in accordance with numbering series applicable in the lab

4.1.7.  All SOPs will have the following information included:

4.1.7.1.  Purpose / applicability - preparation , implementation and maintenances

4.1.7.2.  Responsibility – describe reviewing and signing of SOP

4.1.7.3.  Material and equipment

4.1.7.4.  Procedure – methodology and process

4.1.7.5.  Terms and abbreviation - key terms

4.1.7.6.  References -

4.1.7.7.  Appendices

4.1.7.8.  Version table- Retired and Current SOP Titles, numbers and dates, number of pages

4.1.7.9.  Review and updating table – reviewing

4.2.  Preparing new or updating SOPs:

4.2.2.  If a new SOP is required:

4.2.2.1.  A member of the technical staff for that section will prepare a draft SOP and submit it to the laboratory director or designee(s).

4.2.2.2.  The SOP will be reviewed by the laboratory director or designee(s) for accuracy and completeness.

4.2.2.3.  The SOP will be approved by the laboratory director or designee and entered into a control log that designates the SOP number, title, applicable section(s), version and effective date.

4.2.2.4.  All laboratory staff will be trained on the new SOP, and the training will be documented.

4.2.2.5.  All locations of copies of the SOP will be documented within the SOP control log.

4.2.2.6.  The SOPs will be maintained in the applicable section(s) and with the laboratory director or designee(s) at a minimum.

4.3.  Updating previous SOPs:

4.3.2.1.  As SOPs are annually updated they will meet the standard outlined in this SOP. All SOPs will meet this standard no later than one year from this SOP’s effective date plus or minus two months. Alternatively, the annual SOP review can be staged to enable the lab director or designee to efficiently review the entire lab SOPs.

4.3.2.2.  A review and updating log will be maintained with all original copies of the SOP, see appendix 7.1 as an example.

4.3.2.3.  Any changes to SOPs must go through the same approval procedure as a new SOP.

4.3.2.4.  The laboratory director or designee(s) is required to perform an annual review of the SOP and it will be documented along with the SOP. The documentation will include the reviewer’s initials and date that the review was conducted.

4.4.  Retiring of SOPs

4.4.2.1.  All previous versions of the SOP will be maintained for two years past the discontinuation of the procedure or the use of the equipment or IAW with the study protocol.

4.4.3.  The retired SOPs will be kept in a separate folder out from the lab working area

4.5.  SOP Training Requirements

4.5.2.  Initial training is required for all new personnel on all applicable SOPs for the individual’s duty title; the training will be documented and initialed by the trainer and the trainee.

4.5.3.  A copy of the training documentation will be maintained with all original copies of the SOP and also be filed in the continuous training files.

4.5.3.1.  An example of the training documentation log to accompany the SOP is in

appendix 7.3

4.5.3.2.  An Example of the training documentation log for personnel files is in appendix 7.4

4.5.3.2.1.  All of the training must be initialed prior to the employee starting to perform his/her duties. For current employees the list will be completed upon the completion of required annual training.

4.5.3.2.2.  Employees will sign for having read and understood the SOPs within one month before OR one month after the SOP approval and effective dates (appendix 7.6)

4.5.4.  Training on applicable SOPs will also be conducted annually along with the annual review.

5.  Explanation of Abbreviations and Terms:

5.1.  CRC- Clinical Research Centre.

5.2.  KEL- Kericho Laboratory.

5.3.  SOP- Standard Operating Procedure.

5.4.  IAW- In accordance with

5.5.  USAMRU- united state of America medical research unit

6.  References:

Reference Number or Authors / Document Title
6.1. / CLIA ’88 Homepage – http://www.cms.hhs.gov/clia/
6.2 / WRAIR SOP FORMAT FOR SOPs

7.  Forms and Appendices:

Form or Appendix Number / Title
7.1. / SOP Copy Control and Updating Log
7.2. / Implementation and changes to sop
7.3. / SOP Training Documentation Log for SOP files
7.4. / SOP Training Documentation Log for personnel files

8.  Version Table:

Original: (Retired)
Title: Standard for Preparation and
Maintenance of SOPs / Dated:
March 04 / SOP No.:
USK01 / No.
Pages:10
Version 1: (Current)
Title: Standard for Preparation and
Maintenance of SOPs / Dated:
June 07 / SOP No.:
KEL 129 / No.
Pages:10
Version 2: / Dated: / SOP No.: / No.
Pages:
Version 3: / Dated: / SOP No.: / No. Pages:
Version 4: / Dated: / SOP No.:
KEL / No. Pages:
Version 5: / Dated: / SOP No.:
KEL / No. Pages:
Version 6: / Dated: / SOP No.: / No. Pages:

Appendix 7.5

SOP Copy Control and Updating Log

DOCUMENT COPY CONTROL

DATE PRINTED: June 2007 / NUMBER OF COPIES:
SOP DISTRIBUTION
COPY 1 OF 3
LAB / COPY 2 OF 3
QA OFFICE / COPY 3 OF 3
NAS

By Initialing and dating below I understand and approve of the changes to the attached SOP.

SOP CHANGES / Changes Approval
Initials/Date
Date/Initials / Nature of Change / QA / Approving Authority

Appendix 7.6

Training Documentation Log for SOP Files

Kenya Medical Research Institute
US Army Medical Research Unit-Kenya
CRC-KERICHO
Standard Operating Procedure / COPY 1 OF 3 / SOP No: KEL 129
Supercedes:
Effective Date: June 07
Title: Standard for Preparation and Maintenance of SOPs

This SOP has been read and understood by:

Date:
DD-MM-YY / Printed Name / Signature / Date:
DD-MM-YY / Printed Name / Signature

SOP No: KEL 129. Version 1 Page 2 of 11