Document shall be stored under lock and key in documentation room for the corresponding periods defined below (but not limited To): LIST OF QUALITY RECORDS WITH RETENTION PERIODS S.No.TitleLocation/Agency ResponsibleRetention Period1.Record of Management RepresentativeManagement Representative3 Years2.Records of Contract ReviewMarketingTill the customer is in contract3.List of Approved vendorsPurchase/Management Representative3 Years (updates when ever a new vendor … Continue reading Control, Storage, Retention, Retrieval, and Disposal of Document(s). →

1.       OBJECTIVE   1.1      To lay down a procedure for establishing guidelines for reporting of analytical values and rounding off the digits. 2.      RESPONSIBILITY    2.1      Analytical Chemist - Quality Control  - Responsible for expressing the analytical values and  rounding off the digits as per these guidelines. 2.2 In Charge/His Designee  – Quality Control – Responsible to check the reported … Continue reading Reporting of Analytical values and Rounding off the digits →

OBJECTIVE  To lay down a procedure to investigate an Out of Trend results in the product release. 2.0 RESPONSIBILITY       2.1       Quality Control: Analyst        :  Responsible for reporting OOT result and to carry out the investigation. Supervisor   :   Responsible for performing Preliminary Laboratory investigation along with the analyst. Head           :  To initiate and conclude laboratory investigation and ensure … Continue reading Investigation of Out of Trend Results →

1.         Objective To describe the procedure for preventive maintenance of MILLI -Q. 2.         Responsibility Executive  – Instrumentation – To perform the preventive maintenance. Head – Quality Control – To ensure compliance against established schedule. 3.         Procedure 3.1       FOR GENERAL CLEANING: Ensure that the power supply to the instrument is switched ‘ OFF’ before cleaning. Clean … Continue reading Preventive Maintenance of MILLI -Q Water System →

1.0       Objective 1.1       To describe the procedure for preventive maintenance of Agilent   GC 2.0       Responsibility Executive  – Quality Control– To perform the preventive maintenance activity. Head Quality- Quality Control  - To ensure compliance against established schedule. 3.0 Procedure Precautions: Ensure that the power supply power supply to the instrument is switched “off” before starting the … Continue reading Preventive Maintenance of Gas Chromatograph (Agilent) →

1.         OBJECTIVE 1 To lay down a procedure for adjustment of chromatographic conditions for System suitability 2.         RESPONSIBILITY 2.1 Chemist / Executive –QC – To follow the SOP.    2.2       In Charge / His Designee – QC – To ensure the compliance of SOP 3.         PROCEDURE 3.1    The various parameters of a chromatographic conditions shall be adjusted … Continue reading Adjustment of Chromatographic Conditions for System Suitability →

1.0       OBJECTIVE               1.1        To lay down a procedure for Good chromatography practices in Quality control Laboratory.       2.0       RESPONSIBILITY                 2.1      Chemist / Executive - Quality Control - to follow the procedure.              2.2      Group leader / Supervisor – Quality Control to ensure adherence to the procedure.              2.3      Head - Quality Control for implementation … Continue reading Good Chromatography Practices in Quality Control Laboratory →

Objective 1 To describe the procedure for preventive maintenance of Tablet Dissolution Apparatus 2.0 Responsibility Executive  – Quality Control   – To perform the preventive maintenance activity Head - Quality Control            -- To ensure compliance against established schedule 3.0 PROCEDURE 3.1 Precautions: 3.2 Ensure that the power supply to the instrument is switched “off” before starting … Continue reading Preventive Maintenance of Dissolution Test Apparatus →

OBJECTIVE: 1.1        To describe the procedure for preventive maintenance of HPLC’s 2. RESPONSIBILITY: 2.1       Executive  – Quality Control– To perform the preventive maintenance activity. 2.2        Head - Quality Control  - To ensure compliance against established schedule. 3. PROCEDURE       Precautions: 3.1       Ensure that the power supply to the instrument is switched “off” before starting the … Continue reading Preventive Maintenance of HPLC’s →