Documentation
Clear and accurate documents are a key part of efficient manufacturing. Some of the most common documents in the pharmaceutical and food processing industries include:
- Standard Operating Procedures
- Batch Records
- Equipment instructions
- Validation documents
- Training documents
- and much more
Standard Operating Procedures
Standard Operating Procedures (SOPs) are documents that contain instructions on how to perform a particular task. SOPs can include procedures for control of documents; how to deal with deviations; dress codes; equipment operation, cleaning and maintenance; qualification and validation procedures; cleaning of premises and environmental control; sampling of materials; training and inspections.
Each SOP has a unique identifier that can be referenced by other documents such as other SOPs, test methods, batch records and validation procedures.
Batch Records
Batch Records, or Batch Manufacturing Records (BMRs) are all documents that are associated with the manufacture of a product. They are used to record data during manufacturing operations and provide traceability of the materials used to manufacture the product.
The data recorded in batch records can include bill of materials, equipment identification and settings, dates and times when particular processing operations occurred, measurements and other information specific to the process. As with SOPs, batch records are uniquely identified.
Equipment Instructions
Detailed instructions are required for operating equipment. The instructions often include equipment setup, operation, cleaning and maintenance procedures. Equipment instructions are created based on equipment manuals and other relevant documents from the equipment supplier. The instructions ensure that the equipment is operated and maintained correctly to keep it working as intended and remains reliable throughout its expected life.
Validation Documents
Validation is an important aspect of pharmaceutical manufacturing. There are various types of validation used in GMP manufacturing, but they can be broadly categorised into equipment validation, process validation and cleaning validation.
Equipment validation, or qualification, is conducted to prove that an item of equipment operates and performs as intended.
When various items of equipment are connected together as part of a larger system in a manufacturing process, process validation is used to demonstrate that the process produces materials of the required quality in a consistent manner. Before process validation can be carried out, the equipment used in the process must first be qualified.
Cleaning validation is just as important as process validation. Cleaning validation verifies that a cleaning process for the equipment or system is sufficient to avoid contamination between batches. It is especially important for processing equipment used for the manufacture of different products. Even trace amounts of a drug or food allergen in a product that shouldn’t contain them can have serious consequences.
Training Documents
Training is a critical GMP requirement. Staff must be trained on the various documents covered above. Contractors and consultants may also require training in specific documents so that they can perform their work safely and reliably.
Training records must be kept to prove that staff, contractors and consultants are adequately trained to perform their roles in an effective and proficient manner.