SAMPLING OF SEMIFINISHED PRODUCT Samples collected during granulation or blending stage for solid oral dosage forms shall be considered as semi finished product samples.As per BPRR at the end of the each activity, production executive shall issue “SAMPLE TEST REQUEST FORM” to IPQA personnel. IPQA personnel shall sample and submit all samples to the QC … Continue reading Sampling and Release of Semi finished Product →

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 →