GMP产品包装印刷管理规程(英文)

PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the steps involved for the creation, approval and printing of packaging components.
SCOPE
This SOP applies to all personnel engaged in the creation, approval and printing of packaging components at CURE Pharmaceutical, Oxnard, CA. This SOP applies to printed components for third parties unless the third party has a company SOP in place that both parties agree to follow.
RESPONSIBILITIES
Package Development:
•Determine appropriate packaging components based upon business development and production needs.
•Source packaging components.
•Obtain die-lines from suppliers.
•Perform audits of print suppliers as required.
•Ensure part numbers are placed on all components as required.
•Ensure changes are processed through the change control system.
Business Development:
•For items used in contract manufacturing for a customer, act as the liaison between the customer and CURE to determine customer needs in terms of graphic design, package size and functionality.
•Provide supplement facts approved by R&D to customer for inclusion on packaging components.
•Provide applicable CURE part numbers to the customer for inclusion on packaging components.
•Provide manufacturing specs to customer for packaging including specs for label rolls, pouches, etc.
where it may impact production (if customer is providing packaging).
Creative Director:
•Create die-lines and package component artwork as required.
•Approve print proofs and press proofs as required.
•Send approved artwork files to print suppliers.
Research and Development:
•Provide an approved list of active and inactive ingredients in a formulation.
•Provide supplement facts in MMR to be used on printed packaging components.
Customer:
•Ensure the accuracy of all text on packaging components.
•Ensure compliance with all regulatory requirements for the product.
•Ensure text includes all applicable warnings and allergen listings.
•Provide signed copies of artwork, print proofs and press proofs as requested by CURE.
Quality Assurance:
•Perform audits of print suppliers as required.
•Sign off on artwork specs and print proofs as required.
•Create Master Labels from approved packaging components.
Production:
•Ensure production concerns are met in terms of machinability.
•Approve dyelines and carton blanks prior to printing.
•Ensure lot and exp. area is identified on labels, cartons and other packaging as required and that enough space is available for printing of lot and exp.
REFERENCES
SOP 113 Receipt and Inspection of Printed Packaging Components
SOP 105 Change Control System
SOP 117 Elements and Generation of Master Manufacturing Record
SOP 129 Document Numbering System
DEFINITIONS
Artwork Specification: Computer file of artwork containing dieline, graphics and all colors used that is sent to a printer.
Dieline: The outline of a printed packaging component, usually provided by the printer. The dieline indicates die cuts, folds, and print constraints and is used by the graphic artist to enter text and graphics.
Master Label: Signed copy of actual printed component kept on file at CURE and used as a reference to check subsequent lots of components.
Packaging Component: Materials used to enclose and/or protect products for distribution, storage, sale and use. Press Proof: Actual component from a printing press that shows precisely what the printed piece will look like. Print Proof: PDF (or other) copy of the artwork created by a printer showing the file as it will be printed. Contains dieline, colors, perforations, folds, cutouts and varnish layers as appropriate.
Printed Packaging Component: A packaging component printed with text and graphics used to identify and provide information about the product. Examples include primary package labels, inner cartons and outer packers, and any other printed card or insert enclosed in the package.
PROCEDURE
1. Determine size and style of component
1.1 Once the need for a new or revised printed component is identified, Package Development will
determine the appropriate size and style of the label, carton, packer, or other component.
1.2 Assign a part number. Part numbers are obtained from QA. For a component that has major text
revisions, a unique suffix will be added to the part number to differentiate it on the Master
Packaging Configuration, BOMs, and in the warehouse.
2. Verify size and style of component
2.1 Dieline and Layout Format
2.1.1 Ensure the item is a size that can be handled on the current labeling and packaging
equipment or is a size and shape that can be handled easily if hand applied or
assembled.
2.1.2 Ensure the proper area has been identified for stamping or imprinting of the lot and
exp. date on the component.
2.1.3 Ensure the words Lot: and Best By: are preprinted if required. Verify that the
customer has approved this wording.
2.1.4 Ensure that a no-varnish area is provided if needed. Check with production.
2.1.5 Ensure that the necessary perforations are in place to facilitate bending or tearing of
the label or carton as needed. Check with print supplier that the perforation size
chosen will provide the desired opening or bending feature.
2.1.6 Obtain a die-line from the printed component supplier, or approve a die-line created
by Creative Director.
2.2 Customer approval of package style
2.2.1 Business Development should obtain customer approval of the size and style of the
package component before the text and graphics are created.
2.2.2 Business Development should discuss with customer any possible cost implications
of the package style chosen, either costs incurred directly from printer or costs
incurred from hand packaging or modifications to packaging equipment.
3. Create graphic layout and text layout.
3.1 Graphic Design
3.1.1 Graphic layout is determined by Business Development, Creative Director and the
customer.
3.1.2 Package Development will ensure that chosen graphic style can be printed
successfully.
3.1.3 Business Development should discuss costs with customer for chosen design
including number of colors, special cut-outs, embossing, and varnishing.
3.2 Text
3.2.1 Text should comply with all applicable guidelines for dietary supplements. Customer
is responsible for ensuring compliance.
3.2.2 At a minimum, the following items should appear on a sachet or immediate carton.
Examples are given in right column. Labels will contain abbreviated information
determined by the size of the label.
3.2.2.1 Product Name: Trade Name or Brand Name
3.2.2.2 Description: Oral Thin Film, Oral Strips, Gel, etc.
3.2.2.3 General Usage: Energy, Focus, etc.
3.2.2.4 Flavor: Cherry, Spearmint, etc.
3.2.2.5 Product Class: Dietary Supplement
3.2.2.6 Quantity in Pkg: One Strip, 12 Strips
3.2.2.7 Lot Number/Batch: (printed in production)
3.2.2.8 Exp or Best By :(printed in production)
3.2.2.9 Recommended Use (varies)
3.2.2.10 Caution Statements: Do not take more than 3 Strips per day
3.2.2.11 Warnings: (varies)
3.2.2.12 Supplement Facts: * See Next Section
3.2.2.13 Other Ingredients List inactive ingredients
3.2.2.14 List of Allergens
3.2.2.15 Distributor name and address
3.2.2.16 Place of Manufacture (Made in USA)
3.2.2.17 Package Component Part Number
3.2.3 The following additional items may appear
3.2.3.1 Marketing Info: Great Tasting, Long Lasting
3.2.3.2 Package Instructions: Tear Here
3.2.3.3 Bar Codes (varies)
3.2.3.4 Website info: (varies)
3.2.4 Supplement Facts*
3.2.
4.1 The Supplement Facts Label must appear on all sale packages, such as
sachets and inner cartons.
3.2.
4.2 The Supplement Facts are detailed in the Master Manufacturing Record
and must match.
4. Approval of Artwork
4.1. Once artwork is completed, artwork should be signed by the following groups, according to the
items listed in the responsibilities section:
4.1.1. Customer
4.1.2. Business Development
4.1.3. Package Development
5. Send Files to Printer
5.1. Once artwork is approved, Customer or Package Development sends files to the appropriate
printer. Files are sent in the format requested by the printer.
5.2 Package Development files one hard copy in the Packaging Specifications Book in QA and one
electronic copy in a secure location in the CURE document control folder.
6. Receive and Approve Print Proofs
6.1. Printer will send Print Proofs via email or as hard copies to Package Development.
6.2. Package Development and QA approve Print Proofs based upon signed artwork.
6.3. Package Development sends print proofs to customer for approval
6.4. Package Development sends one copy back to printer and files one copy in Packaging
Specifications Book in QA, and files the electronic copy, if available in a secure location in the
CURE document control folder.
6.5. This is the signal to the printer that items are ready for print and no other changes will be made.
7. Approval of Press Proofs
Press proofs are sometimes created prior to the complete print job being finalized. For digital labels, digital files are sent by hard copy for approval. For other items, the customer or CURE may sign off on a press proof at the printer’s location.
7.1. For Digital Labels, printer will send a press proof for approval.
7.2. Package Development and QA approve Press Proofs based upon Print Proof.
7.3. Package Development sends one copy back to printer and files one copy in Packaging
Specifications Book in QA.
7.4. Press Proofs that are signed off at the printer’s location are not taken back to CURE and are not
archived.
8. After Press Proofs are approved, items are printed and shipped to CURE to await inspection.
REVISION HISTORY。