Aseptic Production 1 Flashcards
Sterile Production • Takes place on two levels
• Industrial – Large scale manufacture • Hospital – Small scale licensed manufacture – Small scale unlicensed manufacture
Industrial Sterile Manufacture
• Large scale production of sterile products
• Hold a manufacturing authorisation (manufacturer’s license)
• Products most likely to be those with a Marketing Authorisation (Product License)
• Must comply with Good Manufacturing Practice for Medicinal Products (GMP)
– See “Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015” (The Orange Guide) for further detail (available through Medicines Complete
Hospital Small Scale Manufacture
• Licensed NHS units
– Queens Hospital, Burton
• Licensed NHS units will hold a manufacturing
authorisation
– Often manufacture unlicensed “specials” (chemotherapetuic toxic agents, eye drops)
– Supply to other NHS Trusts
• Unlicensed NHS units
– Manufacture “to order” (Patient A comes in for a chemotherapy drub B and the drug is made up by the hospital department for the patient on that day)
• Must comply with GMP
Disadvantage of manufacturing license
Obtaining a manufacturing license is very expensive and need to ensure high quality
Quality Assurance
Primary aspect of a good manufacturing practice
Ensuring that the product that you make is exactly the same as the product you made yesterday and the product you will make tomorrow… in its quality, sterility, viability
GMP is part of the QA process and includes the following:
- Processes
- Facilities (premisses and staff) in which the medicine is produced
- Equipment
- Materials
- Procedures
- Storage and transport of completed and raw materials
- Training
- Record Keeping
- Distribution of product
- Product recall - if you discover one of your raw ingredients has something wrong how do you contact all patients that have taken it
- Complaints
Quality Control
• Quality Control is part of GMP (part of the umbrella that is quality assurance) – Sampling – Specifications – Testing – Record keeping – Product release
For example if you produce a batch of 100 eye drops you would sample part of that batch to ensure it is up to the correct standard for viable organisms, content of drug etc. somebody has to set those specification so they are QC’d
GMP
- GMP is essential and you must follow it at all times.
- Remember, GMP applies to all medicinal products and medical devices manufactured in the EEA. (European Economic area)
- There is a separate annex for sterile production. (that covers how your suite is designed and the air quality etc)
Which products should be produced under sterile conditions?
• Any products for injection • Eye drops • Dressings • Irrigation solutions (so if you’re going to clean a wound or perform surgery) • Items for use in surgery – Sutures – Implants
All of these products come from raw ingredients that are not sterile
Skin
Skin is barrier to the outside world. anything under skin is sterile apart from interior gut
Typical non‐licensed hospital products
• Chemotherapeutic agents
• Parenteral nutrition (patients who need to be fed IV, going directly into the blood stream)
• Central IntraVenous Additive Service (CIVAS) – Antibiotic solutions in mini‐bags
– Analgesics e.g. morphine PCA systems (syringes of morphine, after you’ve had a operation) - All of these can be produced centrally by a hospital manufacturing unit, they can either be produced in bulk as a licensed product or in anticipation of a prescription as an unlicensed product
Chemotherapy
chemotherapy is one of the biggest areas of non-licensed hospital manufacture
Typical non‐licensed hospital products - image 1
TPN - filled with fat, lipid and protein solution and various vitamins
Typical non‐licensed hospital products - image 2
Mini bag - dextrose solution.
Mini bag has 2 areas - cap at bottom
- Squeeze just enough liquid into dry powder bottle of ampicillin, give it a shake and it will dissolve. you then turn the bag back upside down and the amp will flow into the bag and then you will remove the vial or leave it in-situ most people remove it. replace the cap and then thats good to go for the patient
- put the giving set in to the second port, so thats how the drug gets into the patient
Typical non‐licensed hospital products - image 3
Classic chemotherapeutic agents
- Etoposide (Injectiong USP 1g/50ml) liquid - so the hospital unit will just be drawing this up into syringes for patients
- DOXO rubicin Hydrochloride for injection USP 50mg powder (bright red) - will have to add a liquid to it to reconstitute it before giving it to a patient
