AVA Certified Three Ways
• IASC Certified Facility
• IASC Certified Raw Material
• IASC Certified Finish Products
AVA Certified Facility
• IASC Auditor Visits SiteInsures that Facility meets GMP & IASC
Standards
• They have a Quality Assurance and Quality Control System
• QA/QC reports to Executive Management
• The Quality Unit has the authority to stop production at any time
AVA Raw Material
• All raw materials are checked for identity and quality before use
• All raw materials are “released” prior to use in production
• Non-conforming raw materials are quarantined and either re-tested or sent back if they finally fail
• All raw materials and packaging components are kept clean until they are used
AVA Certified Facility
• The manufacturing facilities and all equipment are adequate and suitably clean to produce certifiable products
• The facility has adequate washing facilities for production employees
• All employee hygiene and cleanliness are monitored and employees are trained to insure handling cleanliness
AVA Standard Operating Procedures
• Proper equipment cleaning and maintenance
• Receipt, storage, handling and testing raw materials
• Sampling and testing in-process materials
• Methods for controlling microbial contamination
AVA Standard Operating Procedures
• Change control– All changes are approved and documented
• Tracking deviations– All deviations are recorded and approved if
acceptable
• Issuing batch records– Production held until QA/QC releases the
correct and current batch record
• Internal Audits – To provide documentation that all procedures
are being followed properly
AVA Batch Records
• The lot numbers of all raw materials used are recorded in the batch record
• Who weighed and who verified the weighing of each raw material is documented and recorded
• All batch records include adequate instructions for each step of the operation
AVA Batch Records
• Who performed and who verified each step of the operation is recorded
• Yield calculations are recorded in each batch record
• Each piece of equipment used in each step of the operation is recorded
• QA/QC maintains the completed batch records in the event there is ever a question about a particular batch
AVA Cleaning Procedures
• All major equipment cleaning, maintenance and use are recorded in cleaning and use logs
• The cleaning and use logs include date, time, product and batch number of each batch produced
• The cleaning and use logs are signed and dated by the person performing the operation and by a second person verifying the operation
AVA Training Procedures
• All employees are given training in their particular job responsibilities
• All employees are trained in Current Good Manufacturing Practices
• All training is repeated as needed.• All training is recorded and documented• Managers generate a training “matrix” to
show needed training and to document completion of training required.
AVA Labeling Procedures
• All labels are reviewed prior to release to assure the label is correct
• The issuance and use of labels are adequately controlled
• Labels are reconciled by quantity of labels issued, used and returned
• Any excess labels with lot numbers are destroyed
AVA Finished Goods Procedures
• Products are inspected for proper labeling, packaging and coding during the filling and final packaging operations
• Specifications are set for each product• Random samples of products are
taken during compounding, filling, packaging and checked for conformance to the applicable specifications
AVA Finished Products
• All finished products must be “released” by QA/QC prior to shipment
• There is a quarantine space and procedure for all non-conforming finished products
• All finished products are kept clean until they are shipped
• Adequate distribution records are maintained so that a product could be effectively recalled if ever necessary
AVA Sample Retention
• AVA reserves samples of each lot produced
• Amount of samples retained are at least twice the quantity needed to perform release testing over again if necessary
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