Month: October 2021

Engineering  Department Responsibility in Pharmaceuticals


Below are the responsibilities of Engineering personnel in Pharmaceutical Industry (But not limited To) 1. To follow Good Engineering Practice. 2.Preparation and Review of departmental SOPs 3. Preparation and Review of PM schedule, checklist and attending breakdown. 4. Observation and Guideline in installation activities of new equipment's or projects at site. 5. Implementation of SAP 6. To review and undertake … Continue reading Engineering  Department Responsibility in Pharmaceuticals

Audit Trails Reviews for Data Integrity


Introduction : Annex 11 requires that audit trails are regularly reviewed to ensure data integrity. There are a significant amount of inconsistent interpretations about the requirement to regularly review audit trails. Some of the interpretations are that a periodic review of audit trails should be performed to ensure data integrity. Under a periodic review approach … Continue reading Audit Trails Reviews for Data Integrity

Procedure for the cleaning, storage, usage and maintenance of packing machine change parts


1.         OBJECTIVE              To laydown a procedure for the cleaning, storage, usage and maintenance of packing machine change parts. 2.         RESPONSIBILITY    Technical Assistant – Cleaning/storage/Maintenance of packing machine change Parts. Executive  – Responsible for Cleaning/storage/Maintenance of packing  machine change parts. 3.         PROCEDURE                        CLEANING 3.1.1    Dismantle the change parts from the machine. 3.1.2 Clean the change parts, using lint … Continue reading Procedure for the cleaning, storage, usage and maintenance of packing machine change parts

Preventive Maintenance of Auto Coater


  1.0     OBJECTIVE              1.1       To lay down a procedure for Preventive Maintenance of Auto Coater.   2.0     RESPONSIBILITY                                                   All Tec. Assistants - To perform the preventive maintenance activities as per the respective SOP. All Executives (Eng.Dept.) – To prepare and comply the preventive maintenance SOP. All Department Heads – To implement and compliance of this … Continue reading Preventive Maintenance of Auto Coater

Preventive Maintenance of HPHV Autoclave


1.         OBJECTIVE              1.1       To lay down the procedure for Preventive Maintenance of Autoclave 2.         RESPONSIBILITY                                                   Assistant - Engineering &Production  - To follow the SOP Executive - Engineering & Production - To comply the SOP 3.         PROCEDURE 3.1       Monthly Maintenance 3.1.1     Check the Oil level in the FRL unit assembly and refill the oil with … Continue reading Preventive Maintenance of HPHV Autoclave

Preventive Maintenance of Roll Compactor


OBJECTIVE              To lay down a procedure for Preventive Maintenance of Roll Compactor Assistant - Engineering     - To follow the SOP Executive - Engineering     - To Comply the SOP PROCEDURE            Weekly Maintenance   Check the Hydraulic cylinder of augur lifter for proper working and oil leakages. RESPONSIBILITY                                                   Check the oil level in the main motor reduction gearbox … Continue reading Preventive Maintenance of Roll Compactor

Procedure for action to be taken on the adverse report of environmental monitoring of sterile Area


PROCEDURE  (For alert limit) If the colony forming units exceed the alert limit a) Increase the frequency of cleaning from once to twice a shift. b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP     and Cleaning of the processing area is carried out as per respective SOP .     … Continue reading Procedure for action to be taken on the adverse report of environmental monitoring of sterile Area