5. Weighing, measuring, monitoring, and testing equipment critical for ensuring quality should be calibrated according to written procedures, established schedules and using certified or traceable standards.
1. There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejections of materials.
4. Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after prolonged storage or exposure to heat or humidity).
3. Procedures should be established on how to investigate / evaluate any discrepancies found between number of containers labelled and number of labels issued.
5. Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record.
10. Written procedures address the following types of planning:
• Establishment of requirements
• Verification of requirements
• Acceptance procedures
• Quality information systems
• Customer satisfaction
• Change control
2. 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.
3. 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.
5. Designated areas outside of processing zones have been provided for clothing and other personal belongings (Jackets, cell phones, bags, radios, CD players, headsets, pagers).
1. Have procedures been established and used for identifying training needs? Training procedure(s) shall exist for all levels including part-time and temporary staff, management, visitors, contract/construction personnel, consultants, government and customer auditors.
4. Employee training covers general topics such as cGMP, sanitation, safety, environment, SOPs & MSDS. In addition, training is provided on specific work instructions, procedures, equipment operations, or as required to perform a specific job function.
7. Training records must be maintained for all personnel and should include: Date, Topic, Name of Instructor, Employee Signatures, Tests, Quizzes, etc.