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We maintain continual learning and development for our staff so they can deliver the best outcomes on projects. Effective measures shall be taken to protect against metal and extraneous materials. Perform filling, assembling, packing, and other operations in such a way that products are not adulterated. Procedure exists for Out-of-Specification results. What is done with product? Are product standards routinely utilized?
Is production set up to meet Customer Specifications and Requirements? Are there enough resources qualified people, intermediate and final process checks, etc to assure the production of a quality product?
Establish and follow procedure to ensure that correct labels, labeling and packaging materials are issued and use. Procedures should be established to reconcile the quantities of labels issued, used, and returned. Procedures should be established for the destruction of obsolete and out-dated labels.
Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record. A printed label representative of those used should be included in the batch production record. Identify packages and ingredients with a lot number that permits determination of history and control of batch.
Examine packaged and labeled products to ensure that they have the correct label and lot. Ensure that proper line clearance procedures are in place and utilized during changeovers. Does the organization have an established and maintained quality management unit? There is a management representative with defined authority and responsibility for meeting customer compliance. Qualified technical personnel are available for design, process, product, and service support. A quality manual has been developed which details the quality system of policies and procedures.
The responsibility for updating and revising the quality manual and system is well defined. Company quality objectives are documented, signed and dated. Quality objectives are communicated, understood, and maintained throughout the organization. Written procedures address the following types of planning:. Quality costs are used for evaluating and planning. Documented evidence exists that advanced quality planning activities are reviewed with customers. Goals are regularly reviewed by top management.
There is a system in place to verify that objectives are met and quality policy is adhered to. Achievement of quality objectives is a high priority in overall performance reviews. The quality manual is regularly reviewed, revised, and communicated throughout the organization. There is a documented and objective process in place to measure and track customer satisfaction. Internal audits are conducted semi-annually or scheduled on the basis of status and importance of activity.
Audit includes work environment and general housekeeping. Internal audit results are documented and brought to attention of management.
There is an established and documented complaint investigation and response program. Corrective actions are timely, recorded, and evaluated for effectiveness. Job descriptions throughout the organization include responsibilities for supporting quality objectives.
An adequate number of qualified personnel exist to perform functions in manufacturing, packaging and QA. Personnel should wear clean clothing suitable for the manufacturing activity. Additional protective apparel, such as head, face, hand, and arm coverings should be worn, when necessary. Any person, by medical examination or supervisory observation, that is shown to have, or appears to have, an illness, or open lesions, by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials being contaminated, shall be excluded from any operations until condition is corrected.
Personnel shall be instructed to report such conditions to supervisors. Designated areas outside of processing zones have been provided for clothing and other personal belongings Jackets, cell phones, bags, radios, CD players, headsets, pagers.
You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction. Keeping all materials, tools, and plants clean, neat and in good working condition can help manage hazards present in the working area. Conduct routine visual site inspections and check the overall safety of the production place using this GMP Site Walkthrough Checklist. Identify health and safety risks including the presence of mould, unsanitary working areas, improper use of PPE, and unlabelled chemicals.
Use Lumiform to assemble reports and assign actions to authorized personnel when hazards are detected. Download as PDF. Lumiform enables you to conduct digital inspections via app easier than ever before. Digitalize this paper form now Register for free on lumiformapp.
No jewellery earrings, watches, rings, etc worn in manufacture areas. Doors are left closed when they are not in use. No evidence of spitting or any misbehaviour. Uniforms are worn correctly and in good condition. No food containers are used for nonfood use.
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