1. Standard Operating Procedures (SOPs) Lecture 9
Dr. Attya Bhatti
HoD Health care Biotechnology
ASAB-NUST

2. Standard Operating Procedures (SOPs)
‘Detailed, written instructions to achieve uniformity of the performance of a specific function’.
Focus is always set on repeated application of unchanged processes and procedures.

3. Purpose of SOP
Serve as framework for organizational policy – provide direction and structure
Written documentation of best practice
Tells what, how, when, why, and who
Provide foundation for:
job descriptions,
employee training
corrective action and discipline, and
performance review.

4. Help maximum safety and operational efficiency for organisations:
Pharmaceutical organizations
Government organizations
Emergency response operations
Clinical research organizations
Power producing organizations

5. Who is responsible? Study director is mainly responsible for SOPs.
The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP.

6. How are SOP's developed? The Four P's Model Philosophy Policies
Procedures
Practices

7. Elements of an SOP Rationale for SOP
Detailed description of procedure – based on best practice/standards
Monitoring actions
Accountability
Corrective Actions
Date of last review or revision date

8. Writing Styles
SOPs should be written in a concise, step-by-step, easy-to-read format.
The information presented should be unambiguous and not overly
complicated.
The active voice and present verb tense should be used. The term "you" should
not be used, but implied.
The document should not be wordy, redundant, or overly lengthy.
Keep it simple and short.
Information should be conveyed clearly and explicitly to remove any doubt as
to what is required.
Also, use a flow chart to illustrate the process being described.
In addition, follow the style guide used by your organization, e.g., font size and
margins

9. SOP GENERAL FORMAT
SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it.
There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written.
Where possible break the information into a series of logical steps to avoid a long list.
The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the frequency of that procedure being followed, the number of people who will use the SOP, and where training is not routinely available.

10. Title Page
The first page or cover page of each SOP should contain the following information:
A title that clearly identifies the activity or procedure,
An SOP identification (ID) number,
Date of issue and/or revision,
The name of the applicable agency, division, and/or branch to which this SOP applies,
The signatures and signature dates of those individuals who prepared and approved the SOP.
Electronic signatures are acceptable for SOPs maintained on a computerized database.

11. Table of Contents
A Table of Contents may be needed for quick reference, especially if the SOP is long.

12. Text
Well-written SOPs should first briefly describe the purpose of the work or process, including any regulatory information or standards that are appropriate to the SOP process, and the scope to indicate what is covered.
Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section.

13. Text
Denote what sequential procedures should be followed, divided into significant sections; e.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user).
Finally, describe next all appropriate QA and quality control (QC) activities for that procedure, and list any cited or significant references.

14. SOPs Implementation Have available for workers to review
Use to train new employees
Use them for corrective action/refresher training for all employees
Incorporate into written job descriptions and performance reviews so there is alignment
Review and update as needed (i.e new equipment item or employee job changes); at minimum review annually

15. ALCOA Apply ALCOA to achieve data quality.
1. Attributable: is it obvious who wrote it?
2. Legible: can it be readable?
3. Contemporaneous: is the information current and in the correct time frame?
4. Original: is it a copy; has it been altered?
5. Accurate: are conflicting data recorded elsewhere?
for-good-data-and-record-management/

16. The SOPs can be categorized
Instrument SOPs
Protocol SOPs
Solution SOPs

17. Instrument SOPs (S-SOP)
Procedures describing how to use our instruments 
e.g. Fume Hoods, Thermo cyclers, Gel Documentation System

18. Protocol SOPs (P-SOP) Procedures describing methods
e.g. DNA isolation, RNA isolation, Agarose gel electrophoresis, Cell proliferation assay, ELISA etc.  

19. Solution SOPs (S-SOP) Procedures describing preparation of solutions
e.g. 1M TRIS, DNA extraction solution, MTT reagent, Bradford reagent, Cell lysis buffer, Loading dye etc.

20. Factors Affecting SOP Development
Factors that need to be considered for the SOP's to work in the real world environment.
Organizational Factors
Operational Factors
Factors Affecting SOP Development

21. The pros of SOPs Consistency Must be consistent;
consistency in the performing of an operation, whether it is in manufacturing or department administration. The more consistent the process is from person to person, the less chance there will be quality problems.

22. The pros of SOPs Reduction of Defects
Reduction of defects is another reason for operating procedures.
A written procedure is like a set of instructions for performing a task. As long as each person performs the task exactly as the process is written, there should not be any defects.

23. The pros of SOPs Communication
Another reason for standard operating procedures is a method of communication.
As improvements are made to processes, the operating procedures are updated and each update requires new training. This provides a method to communicate the process changes to all employees.

24. This procedure is applicable to Chemical Pathology Lab of PHLD when
SOP # :
PHLD/ CP/003/01
Revision # : 01
Replaces: 00
Written by:
Dr. ABC
Edited by:
Dr. XYZ
Authorized by:
Dr. 123
Effective Date:
November 2010
1. Scope:
This procedure is applicable to Chemical Pathology Lab of PHLD when
ALT estimation is performed.
2. Purpose:
To streamline the quantitative in vitro determination of serum ALT level through appropriate verification & adequate documentation.
To ensure and monitor the operational phases of ALT estimation in patients blood using standard protocol.

25. 3. Responsibility:
Lab Technician with the help of Lab Assistant & Lab Attendant is responsible to prepare sample for testing, to run both normal and abnormal high controls and ensure control results fulfill the QA criteria to perform the assay as per protocol
Quality Assurance supervisor is responsible to control and manage lab activities in order to ensure efficient processing of requests and timely delivery of service and to scrutinize the final reports.
The Officer Incharge/Pathologist is responsible for overall monitoring and providing support and guidance in problem solving.

26. Requirements
4.1 Specimen
Serum, plasma. (fresh or hemolytic)
 4.2 Materials
Kit from DiaSys diagnostic systems
Roche Multical
Controls (Roche PPU, PNU)
Sample cups
4.3 Equipment:
Vitalab Selectra E Auto Analyzer
Micro lab 300
Pipettes of various ranges
Centrifuge Machine

27. Procedure:
5.1 Collection, Transportation and Accessioning of Chemical Pathology samples.
(see SOP no…..)
5.2 Principle:
L-Alanine + 2-Oxaloacetate ALAT L-Glutamate + Pyruvate
Pyruvate + NADH + H LDH D-Lactate + NAD
5.3 Method:
Referred to Kit Literature.
Referred to EOP Selectra E.
5.4 Linearity:
The test has been developed to determine ALT activities which correspond to a Maximal ∆A/min of 0.16 at 340 and 334 nm or 0.08 at 365nm. When values exceed this range samples should be diluted 1+9 NaCl solution( 9g/L) and result multiplied by 10.
5.5 Interfering Factors and sources of errors:
1. Many drugs can cause elevated level.
2.Salicylates may cause increase or decrease ALT levels.
5.6 Stability: In serum/plasma
3 day at 20-25˚C
7 days at 4-8˚C
7 days at -20˚C

28.   Reporting:
6.1 Reference Range:
In serum/plasma:
With pyridoxal-5-phosphate activation
Women[3] < 34 U/L
Men[3] < 45 U/L
Children[1] days < 25U/L
2-12 monhs < 35 U/L
1-3 years < 30 U/L
4-6 years < 25 U/L
7-9 years < 25 U/L
10-18 years < 30 U/L
Without pyridoxal-5-phosphate activation
Women < 31 U/L
Men < 41 U/L
  Clinical interpretations:
Increase ALT levels is significant in
Hepatocellular disease
Active cirrhosis
Metastatic liver tumour
Obstructive jaundice
Viral, infectious or toxic hepatitis

29. Quality Assurance:
(Ref SOP # ******** on QA Protocols and tools)
8. Reference documents:
Fischbach, F.T.1996.Immunodiagnostic studies. In: A manual of Laboratory and diagnostic tests.5th ed. JB Lippincott company, Philadelphia, PA, USA.pp554 Kit literature