Pharma packaging regulations of NMPA, EMA and FDA

Introduction

Pharma packaging regulations are a set of principles and standards agreed upon for ensuring the safe packaging of pharma products. It includes the industry's best practices for successful packaging operations that result in the safe delivery of pharma products at the hands of its user by protecting the pharma product from all external and internal hazards such as environment, human handling, and extreme weather conditions.

Every market and country has its regulatory bodies that define packaging regulations for that particular market. Every pharma product manufacturer must comply with these regulatory body regulations. If it fails to comply with these regulations, the pharma product manufacturer will not allow it to sell its product in that market.

There are various regulatory bodies globally that take part in constituting packaging regulations. The pharma manufacturer is requires to comply with the regulations of body, in which it intends to produce or market its manufactured drug.

This article covers some basic pharma packaging regulations of China, the United States of America, and Europe.

Brief overview of NMPA EMA and FDA’s effort on packaging management

Regulatory bodies in the US, China, and Europe are responsible for regulating pharma products in terms of quality, safety, and efficiency. Because these markets offer great value and competitive prices, every pharma product manufacturer desires to sell their products in these markets. So, for this reason, regulatory bodies in these regions are responsible for ensuring the safety of pharma products.

Some ways that these regulatory bodies regulate the packaging operations of pharma products include the following.

• To ensure that proper and relevant packaging material, process, and types are selected for a pharma product that ensures product safety and quality until it reaches the hands of patients or its intended user.

• Pharma product is packed with all the relevant information.

• Packaging dimensions are according to the classifications. The packaging can be easily opened and managed by the end-user

• Packaging should provide anti-counterfeit and tamper-evident features.

• Packaging should contain all the relevant labels and insertions.

• To ensure packaging is safe and secure, test the final packed product using various test methods such as packaging integrity.

• Packaging material is appropriately selected for a selected product.

• The packaging indicates drug usage, with all the relevant details, such as manufacturing and expiry date.

Some common packaging regulations of an NMPA EMA and FDA

Let’s discuss some regulations for packaging in light of NMPA, FDA and EMA.

• The pharma product manufacturer should arrange the correct packaging material.

• Approved packaging material procedures, per GMP, must be in place.

• Sample of packaging material for conducting various quality, safety, and compatibility tests must be taken by authorized persons with approved procedures.

• Batch records of the packaging must be evaluated and signed by an authorized signatory before sending them to the quality department.

• The quality department should ensure that packaging material should meet relevant registration requirements.

• Direct contact between the operator's hands and the primary packaging material should be avoided.

• Drug packaging areas should be indicated and laid out.

• If multiple packaging lines are in the same area, they should be segregated to prevent product mix-up and contamination.

• An adequate storage area should be provided for packaging material. It should be marked and indicated.

• Printed packaging materials should be stored in a safe and secure area. The environment of such space must be controlled, and excessive shifts in temperature must be avoided through the use of temperature control systems.

• Automated and electronic equipment used in packaging should be regularly calibrated. The calibration documentation must be maintained and stored for review during a regulatory inspection.

• Packaging material should be issued for use only by designated personnel and should prevent mix-ups of the packaging material.

• There should be approved procedures for the design revision and approval of printed packaging material. 

• Original packaging material with the relevant documents should be stored with appropriate conditions and at the designated locations. 

• In case of any change in printed packaging material specifications, it should be ensured that the correct packaging material is used. The previous version of printed material must be discarded appropriately and immediately.

• Printed packaging material should be protected from unauthorized use and custody. All loose printed labels should be prevented from mixing up. 

• Printed packaging materials should be disposed of by designated personnel by following authorized procedures in case they are expired or cannot be used.

• Each lot or batch of existing packaging material should be given a specific identification number.

• Expired packaging material should be discarded immediately.

• Recyclable packaging containers should be marked.

• Any change in primary packaging materials should only be allowed after qualification and validation activities are completed.

• Packaging instructions should be prepared for every drug strength and dosage form. 

• The batch document should include complete packaging instructions, and consist of the following

• Pack size

• List of all packaging material required for a product or batch

• Sample of packaging material

• Complete procedure of line clearance before executing packaging operations

• In – process controls

• Reconciliation and acceptance limits of packaging material

• The packaging material of different batches should be kept separate from each other

• The packaging process should be recorded and signed by an authorized signatory 

• The packaging date should not be treated as the manufacturing date

Packaging operations

• Operations should minimize cross-contamination mix up or any other foreign bodies

• Packaging lines should be clean and not contain any remaining particles or traces of previous product

• Each packaging line should include clear identification of all the batches or products being packaged

• Packaging materials should be correct without any error in all respects

• If printing is performed offline, steps should be taken to prevent overprinting

• Check and record the correct functioning of the electronic code reader, sensor, or label reader.

• Printing and embossing should be free from fading and corrosion.

• In process checks during the packaging process should consist of the following

• Package appearance

• Components of packaging

• Correct packaging with correct material

• Correctness of printed information

• On time inspection system are accurate and working properly

• If re-packing becomes necessary, it should be approved by authorized personnel.

• Any discrepancy during reconciling printed packaging materials should be thoroughly investigated. The final product should not be released without a proper conclusion.

• After completion of the packaging operation, any unused printed or coded packaging should be destroyed with proper documentation. Unprinted packaging material should be returned to the store or warehouse.

• Packaging should be tested for seal and packaging integrity.

• Operational procedures for changing packaging materials should be in place. 

• If there is a change in the primary packaging material, the quality department must test or verify it for relevant tests or parameters.

Case Study

The pharmaceutical company established a new packaging department in the existing facility. The present facility is not enough for the increased requirements of the organization.

First, a team was constituted to oversee adding a new packaging section. It consists of quality engineering and production personnel.

• Quality personnel is responsible for implementing quality and regulatory requirements. Considering the conditions, it has the power to approve or disapprove any design. The final approval depends upon the quality department. If the quality department is unsatisfied with the design, it can ask the engineering and production departments to change or amend it. This continues until the quality department is satisfied with the design.

• Production personnel is responsible for ensuring all the requirements are served, and all relevant quality and regulatory requirements are implemented. It is responsible for providing all the production requirements to the engineering and quality department. The engineering department will design the machine capacity and area layout depending on the production needs.

• Engineering personnel is responsible for providing all the engineering support such as construction, piping, utilities, electrification, mechanical, and other related works. 

First, engineering personnel prepares the area's layout, indicating machine layout, required utilities, and personal and material exit & entrance. It is also responsible for designing the site, machine, and all the related accessories keeping in view the relevant quality and regulatory requirements.

The production personnel ensures that the design of the area and machine fulfills the production department's capacity and product output requirements. It also ensures that all the relevant regulatory and quality principles are fulfilled.

Finally, quality personnel reviews the design to avoid deviating from the regulatory requirements. For example, the quality department is responsible for 

• The product does not mix with other products or with one batch does not integrate with the batch.

• Enough cleaning measures are taken, and the design should allow easy cleaning before starting a new collection or product

• Every packaging line is provided with provisions for product and process identification.

• Packaging material can be safely stored during packaging operation without mixing.

• Packaging printing facilities are provided

• Printing machines, accessories, and equipment are working satisfactorily without any error or chance of misprinting.

When all the above and other related requirements have been met, the quality department review and give the go-ahead to start the construction of the packaging department. The quality department also monitors during the construction phase. It has the right to stop or change the design if it finds any deviation.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.