SP6403 / 96058
Validation Principles
Assessment 2 - Project
Project Validation Plan
The plan should be 1500 words +/- 10% (excluding references).
The work must be your own and should include a bibliography of source material where appropriate.
All assignments should be uploaded to Blackboard TurnItIn on, or prior to the date specified in your Subject Outline.
A separate signed student submission sheet must also be submitted with the assignment.
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Validation Plan
Project Background
The company you work for is a contract manufacturer that makes a range of soliddose medicines on behalf of several major pharmaceutical companies in Australia.
Business has expanded rapidly over the last 10 years since several of the multinational companies have closed their large factories and asked you to make tablets for them.
One of your major customers has now contacted you and asked you to double the production volume of some products you make for them. You’ve told them you have no spare capacity, but they are insistent, and offer a 5-year exclusive contract if you expand your facility and install new equipment.
You accept their proposal but tell them you will need 8 months to build the new manufacturing room and to purchase and install the equipment. They accept your proposal and tell you the extra products that you will be making on the new equipment for them.
The products are packaging variations of direct compression paracetamol tablets (500mg).
Project Detail
Your company now has to build a new manufacturing suite with blending and compression rooms that contain the following equipment.
• A new 2000L double-cone blender constructed from 316L stainless steel and internally polished to a 240 grit sanitary finish (150 grit exterior finish), fitted with intensifier bars, automated butterfly discharge valve, integrated electronic motor and controls (including start, timer, emergency stop, interlocks) and safety rails. The blender will need 415V power, 240V power and compressed air services connected. It will also need wall-mounted pipework connections to a new dedicated Cleaning-In-Place (CIP) skid located in the adjacent service corridor.
During processing, raw materials will be delivered to the blender by gravity feeding from an upper mezzanine level through a floor penetration. After blending, the material will be discharged by gravity into new dedicated Intermediate Bulk Containers (IBCs) below the blender (in the same room). • A new tablet press with 56-stations that and can produce approximately
400,000 tablets per hour controlled by a modern automation system / Human Machine Interface (HMI). The modular powder feeding system is a twopaddle design that can be upgraded to three paddles. Tablet discharge is via a pneumatic gate. Distinct zones within the press ensure total separation of the production and technical areas – even when the turret is removed. Maximum compression force is 100kN, maximum tablet diameter is 25mm and maximum tablet depth is 21mm. The tablet press will need 415V power, 240V power and compressed air services connected.
During processing, bulk powder will be gravity fed into the tablet press from IBCs on a platform above the press. Discharged tablets will be stored in lined kegs.
• Both new rooms will need fluorescent lighting installed to provide light levels of approximately 1000Lux. The floors will be a non-slip epoxy and the walls and ceilings will built using pharmaceutical grade sandwich panels. The rooms will be serviced by a new HVAC system setting the room temperatures to 22 degrees Celsius and the requirement is to pump enough air through the rooms so that the volume of air in each room is changed 25 times per hour.
In the existing Packaging Hall next door, a new high-speed blister and cartoning line will be installed with multiple work stations:
1. Reel compartment holding forming material unit and splicing table, including barcode verification of foil component.
2. Preheating and forming section
3. Filling station; including product presence control by camera
4. Sealing unit; after sealing, blisters are cooled by cooling plates
5. Multiple function station; for blister perforating, coding and punching (batch ID and expiry dates).
6. Carton feeder, including barcode verification of carton component.
7. Cartoner, including 100% weight checking
8. Laser etching of batch ID and expiry date etching.
Coming off the blister and cartoner line, finished packs will be shrinkwrapped (model Packmatic SW100).
Task
Prepare a Validation Project Plan for the qualification of the new manufacturing rooms and manufacturing equipment, as well as the new packaging line equipment (as outlined above).
The validation plan needs to ensure compliance with Annex 15 of the PIC/S Guide to GMP. It should also consider the PIC/S Recommendations for Validation Master Planning. It should include information on each the following:
(a) Validation Scope: what is to be covered by this plan
(b) Validation Approach: prospective vs concurrent vs retrospective; application of risk management principles etc. with justification,
(c) Responsibilities: high level only
(d) Plant / Process / Product Description
(e) Specific Process Considerations
(f) List of products / processes / systems to be validated (not necessarily a complete list) – consider using a matrix format
(g) Key Acceptance Criteria; high level only
(h) Planning and Scheduling; consider using a matrix format
The plan need not contain all items, processes etc. to be validated. However, it should contain a sufficient number of examples to demonstrate that you understand the requirements, and could complete the task if sufficient time and information were available.
You need to consider what was discussed in the classroom, coupled with your own reading, and apply lessons learnt to this fictitious example.
Links to a Validation Plan template has been provided. You do not have to use this.