Production and Process Controls.
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QSR’s – Production and Process Controls – The FDA require that all processes that could impact product quality, safety or efficacy need to be controlled via defined, documented, approved and released documentation. Documentation includes operating procedures, specifications, forms, bills of materials, workmanship standards, etc.. All process equipment needs to be approved prior to use and maintained, e.g. calibration and preventative maintenance programs. Where process equipment uses software, the software must be validated as acceptable for use.
Where the production environment could impact product quality, it must have defined control requirements established.
All staff who could impact device quality must be competent to perform their roles, competence can be achieved via training, experience and/or education. All such staff must be aware of the potential impact of their roles on patient and user (e.g. clinicians) health and safety.
Any potential for contamination of the product or the process needs to be considered and controls implemented to prevent.
Where any materials are identified as non-conforming to specifications, then procedures need to be in-place to identify, segregate and disposition such materials.
Any significant deviation from expected yields need to be recorded and investigated.
Prevention of cross-contamination during production.When dry materials and products are used in production, special precaution should be taken to prevent the generation and dissemination of dust. There needs to be appropriate air control e.g. supply and extraction of air of suitable quality
Contamination of a starting material or a product by another material or product must be avoided.
Accidental cross-contamination arises from:
uncontrolled release of dust, gases, particles, vapors, sprays or organisms from materials and products in process
residues on equipment
operators’ clothing, skin, etc.The most hazardous, highly sensitizing materials are living organisms, hormones, cytotoxic substances, and other similar materials.
Cross-contamination needs to be avoided by taking appropriate actions e.g.
carrying out production in dedicated and self-contained areas
conducting campaign production followed by appropriate cleaning in accordance with a validated cleaning procedure
providing appropriately designed airlocks, pressure differentials and air supply and extraction systems.The risk of cross-contamination needs to be minimized due to the potential risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air, via:
wearing protective clothing
using cleaning and decontamination procedures of known effectiveness
using a closed system in production
testing for residues
using cleanliness status labels on equipment.Measures to prevent cross-contamination and their effectiveness should be checked periodically according to standard operating procedures.
Production areas require periodic environmental monitoring.
Before any processing operation, all work areas and equipment should be clean and free from any starting materials, products, product residues, labels or documents not required for the current operation.
Products with biological properties: Production & Process ControlsStarting material must be identified in terms of source, origin, method of manufacture and indicated for quality control compliance. Media and culture shall be added to fermenter and other vessels under carefully controlled conditions and must ensure contamination avoidance. Media should be sterilized in situ. In line sterilizing filters for routine addition of gases, media, acids, alkalis, deforming agents, etc., to ferment should be used where possible. Validation must be completed in accordance with pre-defined requirements. Sterilization methods must be fully validated. Inactivation process: measures should be taken to avoid risk of cross-contamination between treated and untreated products.
areas to be dedicated to purification of one product?
requirements for sterilization or sanitization between batches?
define the life span of columns and the sterilization method?In-process controls play an especially important role in ensuring the consistent quality of biological products because certain deficiencies may not be revealed by testing the finished product. Tests that are crucial for quality control but that cannot be carried out on the finished product shall be performed at an appropriate stage of production.
Samples of intermediate and final products shall be retained in sufficient amounts and under appropriate storage conditions to allow the repetition or confirmation of a batch control.
Certain operations require the continuous monitoring of data during a production process e.g. monitoring and recording of physical parameters during fermentation.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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