MAKING MEDICINES PHARMACY at TU Braunschweig

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Exemplary flashcards for MAKING MEDICINES PHARMACY at the TU Braunschweig on StudySmarter:

Expand on secondary packaging 

Exemplary flashcards for MAKING MEDICINES PHARMACY at the TU Braunschweig on StudySmarter:

CLP (Classification labeling and packaging)

Exemplary flashcards for MAKING MEDICINES PHARMACY at the TU Braunschweig on StudySmarter:

COSHH ( CONTROL OF SUBSTANCES HAZARDOUS TO HEALH)
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Exemplary flashcards for MAKING MEDICINES PHARMACY at the TU Braunschweig on StudySmarter:

GMP ( GOOD MANUFACTURING PRACTICE)

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Fire Safety

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Spillages

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Orange Guide
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How to reduce errors: QA

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How to reduce errors: RA

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Role of MHRA in clinical trials 

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Role of qualified person in clinical trials 
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Difference between dispensing and manufacturing 

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Exemplary flashcards for MAKING MEDICINES PHARMACY at the TU Braunschweig on StudySmarter:

MAKING MEDICINES PHARMACY

Expand on secondary packaging 

Secondary: It surrounds the primary packaging and can enclose multiples of the same thing

MAKING MEDICINES PHARMACY

CLP (Classification labeling and packaging)
CLP sets detailed criteria for the labelling elements: pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal, for every hazard class and category. It also sets general packaging standards to ensure the safe supply of hazardous substances and mixtures.

MAKING MEDICINES PHARMACY

COSHH ( CONTROL OF SUBSTANCES HAZARDOUS TO HEALH)
The purpose of the COSHH regulations is to minimise the risks associated with substances that are hazardous to the health of you and your employees, therefore reducing the number of people made ill through exposure to harmful substances. Guidelines include keeping all control measures in good working order; providing information, instruction and training for employees and others; providing monitoring and health surveillance in appropriate cases; planning for emergencies.

MAKING MEDICINES PHARMACY

GMP ( GOOD MANUFACTURING PRACTICE)

#1 Establish Good Written Procedures

#2 Qualify and Validate Processes

#3 Identify Roles and Responsibilities

#4 Keep All Records

#5 Use the Right Facilities and Equipment

#6 Assemble a Competent Team

#7 Practice Good Hygiene

#8 Maintain Facilities and Equipment

#9   Ensure quality

#10 use gmp audit checklists

MAKING MEDICINES PHARMACY

Fire Safety

Make yourself aware of instructions, know where the fire extinguisher is and how to use it, know where the fire alarm is + sound the fire alarm, know where the fire exit is, keep the exits clear and the doors unlocked and open.

MAKING MEDICINES PHARMACY

Spillages

The problem should be dealt with immediately, other members of staff should be made aware so they can keep away from the area, spillage area should be cornered off, operator should be aware of SOP for spillages, a spill kit should be readily available, if its a liquid use an absorbant cloth, if powder use a damp cloth so avoid the chances of inhalation, surfaces contaminated with cytotoxics should be washed with generous amounts of water and the designated cytotoxics spill kit should be used. Incident must be reported and an incidents report should be filled out.

MAKING MEDICINES PHARMACY

Orange Guide
Rules and guidance for pharmaceutical manufacturers and distributors 2017. Code of practice for qualified persons and guidance for responsible persons. Guidance on reporting defective medicines. Standard provisions for manufacturers and wholesale dealers licenses. Brings together new and revised commission written material.

MAKING MEDICINES PHARMACY

How to reduce errors: QA

QA: is everything that assures the quality of the product, ensures all staff are correctly trained, gives trained staff an understanding of GMP, reduces errors by having defined SOPs for every task,  makes sure any equipment used is fit for purpose, schedule of ppm, everything donr should be recorded,  in ensuring all this it reduces errors 

MAKING MEDICINES PHARMACY

How to reduce errors: RA

RA: Identifies any harm to the patient that could occur during the manufacturing process, allows you to take actions to reduce the risk to the patient, every process in the production line should be risk assessed.

MAKING MEDICINES PHARMACY

Role of MHRA in clinical trials 

MHRA: Assess and process applications from companies to conduct clinical trials, provide clinical trial authorisations.

MAKING MEDICINES PHARMACY

Role of qualified person in clinical trials 

QP: Named on license, responsible for overseeing the overall production process (qa), making sure products are fir for purpose (gmp), responsible for releasing products 

MAKING MEDICINES PHARMACY

Difference between dispensing and manufacturing 

Manufacturing is making a product from scratch using raw ingredients following all the correct procedures. Dispensing is dealing with a ready made product which is ready for use  and labelling it + supplying it to patients in accordance with a valid prescription from an appropriate prescriber.

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