What is Clean Room : A clean room is designed in such a way which is having the provisions to reduce or control particulate contamination and to maintain the environmental parameters such as temperature, humidity and Differential pressure. Clean room is a controlled environment that has a low level of pollutants such as dust, airborne … Continue reading ISO 14644 Clean Room Classification →

1.0  Specificity Demonstrate the separation of the analyte from available Diluent, and Blank (swab) with standard solution using the HPLC system. Note:  No other peak should be observed in diluent and Blank (swab) at the retention time of analyte. 2.0 System Precision The precision as measured by multiple injections of a homogenous standard solution indicates … Continue reading Validation of HPLC Method For Cleaning Validation →

1.0 Sink Conditions for non-compendial Dissolution Method Determine the solubility of active drug substance in the dissolution medium at room temperature.  In case of very soluble compounds demonstrate that two times the amount of active drug substance in one tablet or capsule will completely dissolve in the designated volume of dissolution medium at room temperature.  … Continue reading Validation Of Dissolution Method By HPLC →

The below mentioned parameters are required to be complies during validation of HPLC method for Assay test. 1.0 Specificity : Demonstrate the separation of the analyte from Placebo. Conduct the following forced degradation studies to obtain degraded sample, preferably 10 – 50% degradation and demonstrate the separation of the analyte from degradants. Heat, if necessary, … Continue reading Validation of HPLC method for Assay →

 1.        OBJECTIVE To lay down a procedure for qualification of visual inspectors for media fill vial inspection. 2.         RESPONSIBILITY 2.1 Technical Assistant – To undergo the qualification test. 2.2   Microbiologist – Preparation of vials / check for qualification. 3.       PROCEDURE 3.1    Materials and Equipment Required 3.1.1 Sterile Vials 3.1.2 Rubber stoppers 3.1.3 Flip off seals 3.1.4 … Continue reading Qualification of visual inspectors for media fill vial inspection →

Below mentioned are the flow chart for deviation and everybody working in pharmaceutical industry must know the basic of deviation and its steps from login to closer. The person identifying the occurrence of deviation shall be termed as observer and the observer shall inform about the occurrence to the Initiator and deviation shall be initiated … Continue reading Flow chart of deviation in Pharmaceutical →

Below mentioned are the flow chart for change control and everybody working in pharmaceutical industry must know the basic of change control and its steps from login to closer. As we know that if we want to change in any system, equipment, written procedure, documents etc we have to raise change control and it should … Continue reading Flow chart of Change Control →

The scope of this Risk assessment report is to provide the procedure for Quality Risk Management study for the non operational area shutdown and we can save the utility bills of our organization and can implement the same at our respective sites without impacting the product quality. The Approach adopted to carry out risk assessment … Continue reading Quality Risk Management (QRM) Report for Non Operational Area Shutdown →

Below are some useful questions and answers related to Laboratory incidents which will be useful for the persons those who are working in pharmaceutical & other contract Laboratories....

Below are some useful questions and answers related to Corrective action and preventive action which will be useful for the persons those who are working in pharmaceutical industry.... Pl read, share and comments if you like....