test #1 (16/21)

An important part of GMP work in a company is to work continuously with the quality system, where the life science company must write in detail how they work. When the company has control of the processes, they avoid making mistakes and can more easily explain to the authorities that everything is as it should be when the authorities come to visit. The authorities check that all employees follow the same procedure, so nothing is left to chance. The quality system can therefore be seen as a contract with the authorities where the company promises to produce the medicine in a certain way. 

 

Since GMP rules must be interpreted on a company-by-company basis, what the company writes in the quality manual is individual. But risk management and deviation management are often included: 

 

Risk management principles where the company notes where their biggest risks are and how they manage risks so that problems don't occur. 

 

Deviation management is the description of what employees should do if they find themselves in a situation where the usual practice is deviated from. Similarly, they need to know how to handle irregularities around the medicine. For example, if an employee notices that the product looks different or liquid is leaking from a box.

 

 

 

test #1 (17/22)

An important part of GMP work in a company is to work continuously with the quality system, where the life science company must write in detail how they work. When the company has control of the processes, they avoid making mistakes and can more easily explain to the authorities that everything is as it should be when the authorities come to visit. The authorities check that all employees follow the same procedure, so nothing is left to chance. The quality system can therefore be seen as a contract with the authorities where the company promises to produce the medicine in a certain way. 


Since GMP rules must be interpreted on a company-by-company basis, what the company writes in the quality manual is individual. But risk management and deviation management are often included: 


Risk management principles where the company notes where their biggest risks are and how they manage risks so that problems don't occur. 


Deviation management is the description of what employees should do if they find themselves in a situation where the usual practice is deviated from. Similarly, they need to know how to handle irregularities around the medicine. For example, if an employee notices that the product looks different or liquid is leaking from a box.

# test #1 (18/23)

An important part of GMP work in a company is to work continuously with the quality system, where the life science company must write in detail how they work. When the company has control of the processes, they avoid making mistakes and can more easily explain to the authorities that everything is as it should be when the authorities come to visit. The authorities check that all employees follow the same procedure, so nothing is left to chance. The quality system can therefore be seen as a contract with the authorities where the company promises to produce the medicine in a certain way. 

 

Since GMP rules must be interpreted on a company-by-company basis, what the company writes in the quality manual is individual. But risk management and deviation management are often included: 

 

Risk management principles where the company notes where their biggest risks are and how they manage risks so that problems don't occur. 

 

Deviation management is the description of what employees should do if they find themselves in a situation where the usual practice is deviated from. Similarly, they need to know how to handle irregularities around the medicine. For example, if an employee notices that the product looks different or liquid is leaking from a box.

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