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Data Integrity issues Data integrity issue can be found in very simple processes where management is not focusing.  Take example of cleaning and sanitisation process. Most of the organisations records cleaning and sanitisation in the morning so as to start production activities. If Quality unit watch this activity carefully, it can identify lot of data integrity issues. 1. Most of the records are documented with almost same time and period.  I.e if shift starts at 9:00 hrs, you may find cleaning and sanitisation is documented at 8:00 to 8:30 hrs. The duration of cleaning activity in one room will always be similar.  I.e 30 to 40 minutes. 2. If the firm is using floor cleaning machine, you will never find any breakdown.  Neither you may find spare machine. 3. Generally cleaning is performed by contracted workmen and hence it is likely that record may be documented by officers.  This can create lot doubt whether the person is moving along ...

Steam Quality Testing Steam Quality, Purity and quantity can be affected by the design , use and Maintenance of overall steam system. Steam Systems should be designed to ensure that the steam delivered to the sterilizer is saturated steamhaving a steam quality of 97% to 100 %. Steam of poor quality can contribute to wet packs and sub-optimal steam sterilization cycle that might not be identified by bilolgical monitoring. Steam Provides moistire that allows the coagulation of cell wall proteins and supplies the energy that heats the components and maintains their temperature, the combinationof moisture and temperature results in sterilization. The higher the temperature, the shorter the sterilization time required. For proper sterilization, steam requires a number of attributes.  For these reasons, steam quality testing should be applied to steam sterilizers Steam Quality testing is the phrase sometime associated with a series of three physical tests (non condensable ...

Top 15 Reasons for receiving Form 483 observation in Pharmaceutical Companies A FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of Food Drug and Cosmetic Act and Related Acts. Folowing are top reasons for issuance of 483 FORM-   Scientifically Sound Laboratory Controls: Laboratory controls do not includes the establisment of scientifically sound and appropriate specification, standards, sampling plans and test procedure designed to assure that components, drug product containers, closures and in-process materials. Calibration/Inspection/Checking Not Done: Routine calibration, inspection, checking of automatic mechanical or electronic equipment is not performed according to a written program designed to assure proper performance. Cleaning /Sanitizing/Maintenance: Equipment and utensils are not Cleaned, Maintained, and Sanitized...

Temperature Mapping: Basic Requirement for Storage Area  Why Temperature Mapping   Storage areas need to be environmentally mapped to protect product quality and customer safety A comprehensive temperature mapping study will ensure that storage area is accurately monitored, properly maintained and in compliance with all the applicable regulations To Demonstrate by way of documented evidence that the chosen storage area is suitable for the storage of temperature sensitive medicinal products A mapping exercise of proposed storage area will ensure that the company will understand their storage area and identify any potential areas therein that may be unsuitable to storage medicines . A mapping exercise will also inform as to where permanent thermometers should be located.  What regulations and requirement must you comply with Before beginning to temperature mapping plan ensure that following requirements and constraints Calibration: T he ...