SOP for Behavior in Quality Control Department | Pharmaguideline
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  • Apr 17, 2021

    SOP for Behavior in Quality Control Department

    Standard operating procedure to learn how to behave in Quality Control Laboratory in pharmaceuticals.

    1.0 OBJECTIVE

    To clearly lay down the procedure for behavior in the quality control department.

    2.0 SCOPE

    This procedure is applicable to all persons working in the quality control department.

    3.0 RESPONSIBILITY

    3.1 Doing: Technical Assistant/Executive
    3.2 Checking: Executive/Manager

    4.0 ACCOUNTABILITY

    Head of Department

    5.0 PROCEDURE

    5.1 Keep the working place neat and clean.
    5.2 Follow general instruction laid down by the department head.
    5.3 Wear appropriate clothing as per S.O.P.
    5.4 Follow safety guideline as per instruction is given by manufacturers on the container label, while performing hazardous test /handling hazardous chemicals.
    5.5 Carry out analysis as per their respective specification.
    5.6 Follow all respective S.O.P, M.O.A. during any analysis.
    5.7 Follow MSDS of chemicals which is available in chemical analysis room, before performing analysis of hazardous chemicals /materials.
    5.8 Handle the hazardous and toxic chemicals very carefully as per respective S.O.P. in presence of Q.C. incharge.
    5.9 Follow GLP and fill all related records online while performing analysis, properly in respective annexures /records.
    5.10 Before starting any analysis check the expiry of volumetric solution/chemicals/reagents/ instrument calibration due date.
    5.11 Always place back all reagents/chemicals bottles to its proper place after use.
    5.12 Do not keep used glassware on the working platform, but place it properly in tray labelled as “Glassware for washing”
    5.13 Always draw the attention of incharge in case finding any damaged or eligible reagent/chemical bottle label during working. Such labels are to be replaced.
    5.14 Always handle sensitive equipment like analytical balance very gently.

    5.15 Take care to protect data sheet from any damage/spillage on it during its use for reporting.
    5.16 Do not eat drink, chew, smoke while performing the analysis.
    5.17 Do not horse play and chitchat in the laboratory.
    5.18 Behave decently in the laboratory.
    5.19 Maintain discipline at all places.

    6.0 ABBREVIATIONS

    6.1 MSDS = Material Safety Data Sheet
    6.2 Q.C. = Quality control
    6.3 S.O.P.No. = Standard Operating Procedure number
    6.4 G.L.P = Good Laboratory Practices
    6.5 MOA = Method of analysis
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