Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/005 SOP for Behavior in Quality Control Department Page 1 of 4
Effective Date Revision Date
SOP for Behavior in Quality Control Department
Prepared by： X X
Department Name Date
Approved by： Y Y
Department Name Date
Authorized by： Z Z
Department Name Date
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/005 SOP for Behavior in Quality Control Department Page 2 of 4
Effective Date Revision Date
1. Purpose
This procedure defines procedure to learn how to behave in Quality Control Laboratory in
pharmaceuticals
2. Scope
This procedure is applicable to Quality control department..in Humanwell Pharmaceutical
Ethiopia PLC .
3. Validity
This SOP is valid only until next revision date and if it bears control seal.
4. Responsibility
It will be the responsibility of the microbiologist to follow the procedure. Quality assurance
manager is responsible for SOP compliance.
5. Material and Equipment
None
6. Procedure:
6.1. Keep the working place neat and clean.
6.2. Follow general instruction laid down by department head.
6.3. Wear appropriate clothing as per S.O.P.
6.4. Follow safety guideline as per instruction given by manufacturers on container label,
while performing hazardous test /handling hazardous chemicals.
6.5. Carry out analysis as per their respective specification.
6.6. Follow all respective S.O.P, M.O.A. during any analysis.
6.7. Follow MSDS of chemicals which is available in chemical analysis room, before
performing analysis of hazardous chemicals /materials.
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/005 SOP for Behavior in Quality Control Department Page 3 of 4
Effective Date Revision Date
6.8. Handle the hazardous and toxic chemicals very carefully as per respective S.O.P. in
presence of Q.C. incharge.
6.9. Follow GLP and fill all related records on line while performing analysis, properly in
respective annexures /records .
6.10. Before starting any analysis check the expiry of volumetric solution/chemicals/reagents/
instrument calibration due date.
6.11. Always place back all reagents/chemicals bottles to its proper place after use.
6.12. Do not keep used glassware on working platform, but place it properly in tray labelled as
“Glassware for washing”
6.13. Always draw attention of incharge in case finding any damaged or eligible
reagent/chemical bottle label during working. Such labels are to be replaced.
6.14. Always handle sensitive equipment like analytical balance very gently.
6.15. Take care to protect data sheet from any damage/spillage on it during its use for
reporting.
6.16. Do not eat drink, chew, smoke while performing the analysis.
6.17. Do not horse play and chitchat in laboratory.
6.18. Behave decently in laboratory.
6.19. Maintain discipline at all places.
7. ABBREVIATIONS
MSDS = Material Safety Data Sheet
Q.C. = Quality control
S.O.P.No. = Standard Operating Procedure number
G.L.P = Good Laboratory Practices
MOA = Method of analys
8. Related Documents /Applicable document/
None
9. Revision History
Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/QC/005 SOP for Behavior in Quality Control Department Page 4 of 4
Effective Date Revision Date
Version
Revision Description
No.
1 New
