This Quality Standard describes the requirements for the preparation, generation and approval of new or revised Packaging Masters and Batch Packaging Orders.
3. A master version number is assigned to each new Packaging Master. The master version number is incrementally increased each time the Packaging Master is revised.
4. Information that will be used to prepare a Packaging Master is obtained from technical, marketing, packaging development/engineering and regulatory personnel, as appropriate, within the company.
5. A Packaging Master shall contain the following information (Information may be included by reference to other approved documents such as SOPs or line logs.):
7. The proposed Packaging Master shall be approved by designated personnel in production and QA/QC. The expiration dating interval for the package described by the Packaging Master is assigned by quality assurance and appropriately documented.
8. A final printed copy of the Packaging Master is reviewed for accuracy against verified source information, signed and dated by one authorized person and independently verified, signed and dated by a second authorized person. The official signed Packaging Master is retained in a readily retrievable file. All documents associated with the approval of the Packaging Master are maintained in a secured historical file to assure retrievability. These historical documents shall be retained according to a document retention policy.
9. A plan for implementation of the new/revised Packaging Master shall be followed that assures compliance with pertinent local government regulations and requirements.
10. Procedures shall be in place and followed to assure that changes to materials and components, labeling copy codes or revision codes, special imprint information, expiration date intervals and other information required to comply with local government regulations are implemented by revising the appropriate Packaging Master.
11. QA/QC must approve all changes to Packaging Masters that could affect product integrity and/or assignment of the expiration date interval for the product. Such changes would include, but are not limited to, the following; any changes in the material or design of the primary packaging components, any changes to secondary packaging components that could affect product integrity and stability, a new product, a new package size, any changes in a packaging operation process and process control systems that could affect the integrity and stability of the product.
12. Procedures that describe the preparation of Packaging Masters shall be approved by quality assurance.
2. Each Packaging Order may be assigned one or more unique identification numbers, which may be further divided into sub-parts. Procedures shall be in place and followed to assure that the same Packaging Order identifying number is not used more than once. The coding system for Packaging Order numbers shall be distinguishable from the coding system used for batch number assignments to components, materials and products.
3. The copy codes or revision codes for labeling materials and unique identifiers for packaging components are verified to be accurate by comparison to source documents. The verification is documented on the Packaging Order.
Related: Preparation of Batch Manufacturing Record (BMR)
4. The Packaging Order shall be prepared to include a description of the packaging of one or more batches of product. The following variable information is added to the Packaging Order to assure that products are packaged with the correct components and labeling and are properly identified to allow company QA and Regulatory Agencies to investigate any problems that may arise in commercial channels and determine whether other batches could be involved with the same problem;
6. A procedure shall be established to assure that changes to a Packaging Order, once it has been issued, are properly documented and approved by designated individuals.
7. Procedures that describe the preparation of Packaging Orders must be approved by QA/QC.
A. Preparation and Approval of a Packaging Master
1. A unique identifier using an approved coding system shall be assigned to each proposed finished packaged product to distinguish, at a minimum, differences in testing, specifications, expiration dating, processing sites, package sizes and units of sale.4. Information that will be used to prepare a Packaging Master is obtained from technical, marketing, packaging development/engineering and regulatory personnel, as appropriate, within the company.
5. A Packaging Master shall contain the following information (Information may be included by reference to other approved documents such as SOPs or line logs.):
- Name and strength of the product and unique identification code,
- The final presentation of the assembled finished packaged product into units of sale (for example, 6 bottles of 100 count tablets, bundled in a tray containing 6 bottles each),
- A complete list of the components specified by their title and unique identification codes (sometimes referred to as a Bill of Materials),
- A unique identifier associated with the current version of the labeling,
- Expiration dating interval for the product, where this is a regulatory or company requirement,
- Controlled Substances Number, if applicable,
- Requirements for special imprinting information on labeling,
- Special packaging instructions and storage requirements,
- Equipment to be used,
- Description of packaging operations including any subsidiary operations,
- Instruction for in-process sampling and testing, with limits,
- Provisions for line clearance.
7. The proposed Packaging Master shall be approved by designated personnel in production and QA/QC. The expiration dating interval for the package described by the Packaging Master is assigned by quality assurance and appropriately documented.
8. A final printed copy of the Packaging Master is reviewed for accuracy against verified source information, signed and dated by one authorized person and independently verified, signed and dated by a second authorized person. The official signed Packaging Master is retained in a readily retrievable file. All documents associated with the approval of the Packaging Master are maintained in a secured historical file to assure retrievability. These historical documents shall be retained according to a document retention policy.
9. A plan for implementation of the new/revised Packaging Master shall be followed that assures compliance with pertinent local government regulations and requirements.
10. Procedures shall be in place and followed to assure that changes to materials and components, labeling copy codes or revision codes, special imprint information, expiration date intervals and other information required to comply with local government regulations are implemented by revising the appropriate Packaging Master.
11. QA/QC must approve all changes to Packaging Masters that could affect product integrity and/or assignment of the expiration date interval for the product. Such changes would include, but are not limited to, the following; any changes in the material or design of the primary packaging components, any changes to secondary packaging components that could affect product integrity and stability, a new product, a new package size, any changes in a packaging operation process and process control systems that could affect the integrity and stability of the product.
12. Procedures that describe the preparation of Packaging Masters shall be approved by quality assurance.
B. Preparation and Approval of a Packaging Order
1. A Packaging Order shall be prepared as an accurate reproduction of the approved Packaging Master. The Packaging Order shall be checked for completeness, dated and signed by an appropriately qualified second individual.2. Each Packaging Order may be assigned one or more unique identification numbers, which may be further divided into sub-parts. Procedures shall be in place and followed to assure that the same Packaging Order identifying number is not used more than once. The coding system for Packaging Order numbers shall be distinguishable from the coding system used for batch number assignments to components, materials and products.
3. The copy codes or revision codes for labeling materials and unique identifiers for packaging components are verified to be accurate by comparison to source documents. The verification is documented on the Packaging Order.
Related: Preparation of Batch Manufacturing Record (BMR)
4. The Packaging Order shall be prepared to include a description of the packaging of one or more batches of product. The following variable information is added to the Packaging Order to assure that products are packaged with the correct components and labeling and are properly identified to allow company QA and Regulatory Agencies to investigate any problems that may arise in commercial channels and determine whether other batches could be involved with the same problem;
- Manufacturing batch number(s) to be packaged. Note: One or more manufacturing batches may be packaged under one Packaging Order if this is allowed by local regulations.
- Label batch number. Note: Each packaging order is assigned a single batch number.
- The expiration date for the finished packaged batch.
- Special instructions for imprinting information on labeling.
- Quantity to be packaged.
- Other variable information, as needed, to assure the product is packaged to conform to local regulatory requirements.
6. A procedure shall be established to assure that changes to a Packaging Order, once it has been issued, are properly documented and approved by designated individuals.
7. Procedures that describe the preparation of Packaging Orders must be approved by QA/QC.
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