Aloe Vera of America:A Quality IASC-Certified Producer of Aloe Vera

Presented by Walt Jones

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

AVA Earned and Proudly Displays the IASC Seal