cGMP Gap Analysis

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cGMP Gap Analysis

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The cGMP Gap Analysis is a one-time audit of a facility that is a full FDA/ GMP evaluation at a flat rate. This audit is designed to evaluate the facility, find the compliance pitfalls that might exist and see where your company is at compliance wise.

Cannabis Compliance Experts








 


The Authority on Cannabis & Hemp Regulations

Allay is comprised of former Denver public health cannabis regulators with over 31 years of collective, regulatory experience. Simply put, we are the  most knowledgeable,  professional and effective Compliance Consulting Team on the market. Together we can help you interpret cGMPs and painlessly get through the certification process.

We understand the hectic pace of running a successful cannabis business. We understand that succeeding sometimes means that you don’t have the time to stop and create numerous SOPs, much less implement a robust quality management system. Allay Consulting can do all of this for you and more, while you maintain normal business operations.

cGMP Certification for Cannabis Businesses – Be a Leader in the Industry

A one-time cGMP Gap Analysis is an audit of a facility consists of full FDA/ GMP evaluation at a flat rate. Allay will schedule and conduct the audit and within 72 hours of the end of the audit will provide your company with a full report including all violations observed, concerns, and talking points. This audit is designed to evaluate the facility, find the compliance pitfalls that might exist and see where your company is at compliance wise. This can give you an idea of where your company is at and how you want to move forward. If a contract for a 12-month contract is signed this will be the first visit that will take place during the first month of the contract.

Completion of the cGMP certification process typically takes 155-191 billable hours; therefore, Ally Consulting recommends at least 20 billable hours per month to start the process. This will ensure that your company is moving at a good pace and seeing results. If your business needs or timeline changes, Allay Consulting’s contracts are flexible and you can choose to increase or decrease the hours per month (with proper notice).

What is cGMP?

cGMP Gap Analysis Certification

cGMP stands for current Good Manufacturing Practices. The regulations were created by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act and cover manufacturers of food, dietary supplements, cosmetics, medical devices, and prescription drugs.

cGMP regulations require a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. This quality management system helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity. Not only does cGMP help businesses prevent hazards such as contamination or errors, it ensures that products are safe for consumers, every time.

Consumer Safety: cGMP certification helps protect the consumer from purchasing ineffective, contaminated, or inaccurately labeled products. Consumers have an expectation of safety when buying products, and cGMP certification helps increase brand confidence. In the wholesale food manufacturing world no one will even buy your product if your company doesn’t have this basic certification.

Brand/Investment Protection: cGMP certification helps protect the manufacturer and brand from FDA enforcement such as warning letters, cease and desists, product seizures, or recalls. This is the number one risk mitigation for all brands, partners, and investors alike.

Marketing Tool: cGMP certification can be a powerful marketing tool that sets compliant businesses apart from the competition. This certification can be advertised on your website to let consumers know that your business follows a high standard for safety and quality, making your business among the best of the best in the industry.

Read More – The Top Five Reasons Businesses Should Become Certified

 

Why is cGMP certification important?

cGMP Gap Analysis Certification

Why is cGMP certification important?

cGMP Gap Analysis Certification

Consumer Safety: cGMP certification helps protect the consumer from purchasing ineffective, contaminated, or inaccurately labeled products. Consumers have an expectation of safety when buying products, and cGMP certification helps increase brand confidence. In the wholesale food manufacturing world no one will even buy your product if your company doesn’t have this basic certification.

Brand/Investment Protection: cGMP certification helps protect the manufacturer and brand from FDA enforcement such as warning letters, cease and desists, product seizures, or recalls. This is the number one risk mitigation for all brands, partners, and investors alike.

Marketing Tool: cGMP certification can be a powerful marketing tool that sets compliant businesses apart from the competition. This certification can be advertised on your website to let consumers know that your business follows a high standard for safety and quality, making your business among the best of the best in the industry.

Read More – The Top Five Reasons Businesses Should Become Certified