Base Innovation & Development

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Base Quality

The PCCA Standard Overview

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At the heart of our API Manufacturer Qualification Program is our extensive API Manufacturer Qualification Assessment which considers over 40 important factors within the manufacturer’s quality management system, manufacturing and materials management systems, and distribution system. The assessment covers everything from facilities and equipment to processes, personnel and paperwork.

Our proprietary assessment also considers larger qualifications such as FDA registration, FDA inspection, current good manufacturing practices (CGMPs), and inspections by other health authorities.

FDA registration
The FDA regulates domestic manufacturers as well as foreign manufacturers who sell products in the U.S. All of them have to register with the FDA, and they have to register their products as well.
FDA inspection
The FDA inspects all of the manufacturers of FDA-approved drug products (i.e., finished drug products), but it does not inspect all API manufacturers. This is why it is important to us that the manufacturers we qualify have been inspected by the FDA or their local regulatory agencies.
Current good manufacturing practices (CGMPs) compliance
Various regulatory agencies around the world establish and enforce CGMPs, which are requirements that ensure manufacturers use the proper methods, facilities and controls to consistently make active pharmaceutical ingredients and drug products according to high standards.
Inspection by other health authorities based on the location of the manufacturer (e.g., EU, Canada, Australia, Japan, UK, etc.)

Sample Testing

Even if a manufacturer passes our API Manufacturer Qualification Assessment, we also obtain a sample of the chemical we plan to buy from them and test it in our Quality Control lab like we do with every other chemical we receive.

The lab analyst performs an identity test using Fourier transform infrared spectroscopy (FTIR) and compares the results with the latest USP compendial standards. Then they assess the chemical with any of the following methods and criteria that are applicable:

Refractive index
Brix
Melting point
Specific gravity
Particle size
Solubility
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pH
Other chemical identifications

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The PCCA Standard^™

Our commitment to going beyond what is required.

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Every day, we make a choice to define ourselves by high quality, not low price. We want to do everything we can to help you give your patients reproducible results and the best clinical outcomes possible, because your patients and your pharmacy matter to us. That’s why, every day, we choose to go above and beyond what is required and hold ourselves to The PCCA Standard.

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We set the bar high because we want you to have a reliable supply of chemicals that consistently meet The PCCA Standard, above and beyond USP specifications. Because your pharmacy and patients matter to us, and because vultr服务器管理客户端下载-vultr服务器管理器手机版v1.1.0 ...:2 天前 · vultr服务器管理器手机版是一款专业的手机vultr服务器管理器软件，支持远程vultr服务器连接、shell伋码连接、服务器连接、自定义脚本辅助等功能，完全免费，帮你降低服务器压力，节约资金压力！

To ensure that we find the best active pharmaceutical ingredient (API) manufacturer every time, we developed PCCA API Manufacturer Qualification Program.

Manufacturer Assessment

At the heart of our API Manufacturer Qualification Program is our extensive API Manufacturer Qualification Assessment which considers over 40 important factors within the manufacturer’s quality management system, manufacturing and materials management systems, and distribution system. The assessment covers everything from facilities and equipment to processes, personnel and paperwork.

Our proprietary assessment also considers larger qualifications such as V2Ray使用教程：节点搭建，配置及软件下载方法 – The ...:2021-6-15 · 到此V2Ray的安装、设置和优化就全部完成了，接下来的一步就是在手机或电脑上下载安装V2Ray客户端。首先介绍用于手机或平板电脑的V2Ray客户端。安卓用户需要安装的V2Ray客户端名为 V2RayNG ，可伍在Github上下载（点击此处前往下载页面），当然如果手机安装有Google Play服务也可伍在Google Play商店上 ... (CGMPs), and V2ray windows客户端V2RayW配置及使用教程_重庆seo博客:2021-3-23 · v2rayW是windows平台上基于v2ray核心的一款简单UI程序，目前仅支持vmess协议，不支持shadowsocks和socks5。本文详细介绍v2rayW的安装和配置使用步骤，希望能帮到用v2rayW的网友。

FDA registration
The FDA regulates domestic manufacturers as well as foreign manufacturers who sell products in the U.S. All of them have to register with the FDA, and they have to register their products as well.
FDA inspection
The FDA inspects all of the manufacturers of FDA-approved drug products (i.e., finished drug products), but it does not inspect all API manufacturers. This is why it is important to us that the manufacturers we qualify have been inspected by the FDA or their local regulatory agencies.
Current good manufacturing practices (CGMPs) compliance
Various regulatory agencies around the world establish and enforce CGMPs, which are requirements that ensure manufacturers use the proper methods, facilities and controls to consistently make active pharmaceutical ingredients and drug products according to high standards.
Inspection by other health authorities based on the location of the manufacturer (e.g., EU, Canada, Australia, Japan, UK, etc.)

Sample Testing

Even if a manufacturer passes our API Manufacturer Qualification Assessment, we also obtain a sample of the chemical we plan to buy from them and test it in our Quality Control lab like we do with every other chemical we receive.

The lab analyst performs an identity test using Fourier transform infrared spectroscopy (FTIR) and compares the results with the latest USP compendial standards. Then they assess the chemical with any of the following methods and criteria that are applicable:

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Brix
Melting point
Specific gravity
Particle size
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pH
Other chemical identifications

PCCA Formula Testing

We also verify the chemical with our Formulation Development department, and they conduct further testing to ensure that the chemical works in our formulas when necessary. Because we won’t create formulations for our members with products that we don’t stand behind.

Manufacturer Reassessment

Not only do we extensively assess API manufacturers and their products before we approve them as a source, we then re-assess the manufacturer every two years. We also verify their licenses initially and annually thereafter with the appropriate regulatory agencies.

Manufacturer Assessment

At the heart of our API Manufacturer Qualification Program is our extensive API Manufacturer Qualification Assessment, which considers over 40 important factors within the manufacturer’s quality management system, manufacturing and materials management systems, and distribution system.

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Even if a manufacturer passes our API Manufacturer Qualification Assessment, we also obtain a sample of the chemical we plan to buy from them and test it in our Quality Control lab like we do with every other chemical we receive.

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We also verify the chemical with our Formulation Development department, and they conduct further testing to ensure that the chemical works in our formulas when necessary. Because we won’t create formulations for our members with products that we don’t stand behind.

Manufacturer Reassessment

Not only do we extensively assess API manufacturers and their products before we approve them as a source, we then re-assess the manufacturer every two years. We also verify their licenses initially and annually thereafter with the appropriate regulatory agencies.

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We have developed this comprehensive quality system because The PCCA Standard is about more than a chemical. It’s about a pharmacy, a physician and a patient — every single time.

PCCA is an FDA-registered and -inspected chemical repackager and relabeler. We meticulously evaluate every lot of chemical we receive — this means there are over 20 checks, tests and verifications. Dive into our quality systems by exploring the links in the map below.

01 Chemical Receiving

First, we inspect its container for damage and cleanliness
Next, we verify all of its documentation and labeling
We then take a sample of the chemical and send it to our Quality Control lab for testing

02 Quality Control (QC) Testing

Once a chemical goes through Receiving, lab analysts on our QC team:

Verify that the chemical has been released by the FDA, and that the manufacturer and the chemical have been approved through our qualification program
Perform a second verification of all the documentation and labeling
Obtain the original certificate of analysis and check that the specifications and storage conditions of the API accord with manufacturer and/or compendial requirements
Confirm the chemical’s identity through FTIR, compare the results with the latest USP compendial standard, and assess up to nine other factors
Double-check every step and, if the chemical passes, approve it and release it for warehouse storage

03 Chemical Storage

After QC releases the chemical:

The Warehouse Operations team verifies its labeling with the QC certification and place it under proper storage conditions
Any chemicals that require refrigerated or freezer storage are warehoused in a strictly controlled, refrigerated environment at all times
Our warehouses are all kept in check by an environmental monitoring system that records the temperature and humidity of the warehouses, QC lab and repackaging facilities
A backup generator ensures that our operations areas always maintain optimal environmental conditions

04 Chemical Repackaging

To transfer the chemicals we receive from the manufacturer’s container to PCCA containers, we have a process designed from end to end to prevent cross-contamination and mislabeling

Before we repackage a chemical, a chemical repacker again verifies the chemical labeling
The repacker then repackages the chemical in a dedicated clean room under the appropriate environmental conditions to prevent chemical degradation
After repackaging the chemical, the repacker cleans the entire room and then submits the documentation and a sample container of the repackaged chemical to Quality Assurance for review. A sample of every repackaged chemical undergoes Quality Assurance review

05 Quality Assurance (QA) Review:

After repackaging and before the chemical can be shipped out:

A QA technician verifies the chemical’s labeling and all of its documentation, ensuring that it has been repackaged correctly
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The QA technician then sends the chemical sample to QC for identity testing
A QC lab analyst performs an identity test on the chemical to ensure that it is the correct one and matches all of the labeling and documentation
A second QC analyst double-checks the testing results
If the chemical has passed every check and test, QA releases it to the warehouse to be stored and shipped

06 Quarantine, Return, Disposal

If at any point a chemical fails any of these checks or tests — from the moment it is first inspected in our receiving area to the moment it is released after repackaging and QA review — it is quarantined and either returned to the manufacturer or appropriately disposed of
We reject up to 250 lots of chemicals every year

07 Warehouse Shipping

When fulfilling orders, our Warehouse Operations team members use bar code scanners, ensuring that every item pulled for the purchase is the correct one

08 Shipping

Team members select and pack all products under proper environmental conditions, with fulfillment areas for hazmat, non-hazmat, refrigerated and non-refrigerated items
This system ensures that items are stored, pulled and shipped under appropriate conditions and results in over 99% accuracy in order fulfillment at PCCA

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To transfer the chemicals we receive from the manufacturer’s container to PCCA containers, we have a process designed from end to end to prevent cross-contamination and mislabeling

Before we repackage a chemical, a chemical repacker again verifies the chemical labeling
The repacker then repackages the chemical in a dedicated clean room under the appropriate environmental conditions to prevent chemical degradation
After repackaging the chemical, the repacker cleans the entire room and then submits the documentation and a sample container of the repackaged chemical to Quality Assurance for review. A sample of every repackaged chemical undergoes Quality Assurance review

Next Step

Chemical Receiving

First, we inspect its container for damage and cleanliness
Next, we verify all of its documentation and labeling
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Next Step

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Team members select and pack all products under proper environmental conditions, with fulfillment areas for hazmat, non-hazmat, refrigerated and non-refrigerated items
This system ensures that items are stored, pulled and shipped under appropriate conditions and results in over 99% accuracy in order fulfillment at PCCA

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If at any point a chemical fails any of these checks or tests — from the moment it is first inspected in our receiving area to the moment it is released after repackaging and QA review — it is quarantined and either returned to the manufacturer or appropriately disposed of
We reject up to 250 lots of chemicals every year

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Order Fullfillment

When fulfilling orders, our Warehouse Operations team members v2rayn安卓下载 ensuring that every item pulled for the purchase is the correct one

Next Step

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After QC releases the chemical:

The Warehouse Operations team verifies its labeling with the QC certification and place it under proper storage conditions
Any chemicals that require refrigerated or freezer storage are warehoused in a strictly controlled, refrigerated environment at all times
Our warehouses are all kept in check by an environmental monitoring system that records the temperature and humidity of the warehouses, QC lab and repackaging facilities
A backup generator ensures that our operations areas always maintain optimal environmental conditions

Next Step

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Quality Control (QC) Testing

Once a chemical goes through Receiving, lab analysts on our QC team:

Verify that the chemical has been released by the FDA, and that the manufacturer and the chemical have been approved through our qualification program
Perform a second verification of all the documentation and labeling
Obtain the original certificate of analysis and check that the specifications and storage conditions of the API accord with manufacturer and/or compendial requirements
Confirm the chemical’s identity through FTIR, compare the results with the latest USP compendial standard, and assess up to nine other factors
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Next Step

Quality Assurance (QA) Review:

After repackaging and before the chemical can be shipped out:

A QA technician verifies the chemical’s labeling and all of its documentation, ensuring that it has been repackaged correctly
They also verify that the chemical container is clean and in appropriate condition
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A QC lab analyst performs an identity test on the chemical to ensure that it is the correct one and matches all of the labeling and documentation
A second QC analyst double-checks the testing results
If the chemical has passed every check and test, QA releases it to the warehouse to be stored and shipped

Next Step

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We often hear around the industry that many bases are “like” a PCCA base. We enjoy hearing those descriptions because it means that we’re doing the same thing we have for over 35 years: We’re leading the pharmacy compounding industry. We make the choice every day to help solve problems with consistent, high-performing bases that make a difference in patients’ lives.

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We work hard to create innovative bases that can lead to new solutions. We interact with our clinical and formulations teams as well as compounders around the globe to generate ideas for new bases. Then we work with our Base Production team to reproduce the base multiple times, making sure it passes Quality Control testing.

At every step of the development process, we could cut corners, but instead, we make the choice to create the best products every day because we know that the right base can make all the difference.

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The PCCA Standard factors into every single base we make, every day. We handle and store the ingredients for our bases in the same ways that we do other chemicals — we perform over 20 checks, tests and verifications from the moment we receive them to the moment they go into our production facility. This commitment extends to the water we use in our bases, too. That’s why we have an on-site purification system to ensure we are always using USP-grade water.

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We go out of our way to ensure that PCCA supplies compounders with the best products possible. We rigorously qualify manufacturers and carefully test ingredients to ensure that they meet our standards and achieve our desired results in each compounding base.

When we produce a base, our QC Department tests it according to R&D’s specifications. If it doesn’t meet those specifications, for any reason, we reject the product and start over. We want to do everything we can to get the finished base right every single time.

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We know that everything from the chemicals to the base to the formula to the support all add up to the final compounded preparation that can change a life, or even save it. That’s why The PCCA Standard doesn’t just apply to our chemicals and bases; it applies to the formulas we develop and the science behind them, all to help PCCA members confidently and carefully compound prescriptions for their patients.

9400+

Proprietary formulas that help achieve positive, reproducible results for patients.

140+

FormulaPlus^™ formulas with extended beyond-use dates (BUDs).

35+

Bracketed formulas with extended BUDs.

Our Formulation Development team creates, monitors and tests formulas at the request of PCCA members or our Clinical Services department, and to support new PCCA bases and APIs. They also test and update our formulas continually, support them with research whenever possible, and maintain our unparalleled database so that the latest versions are always available.

This means that PCCA members have access to tested, well-supported compounding formulas that abide by the latest regulations, use new and improved technologies, and incorporate the most clinically relevant bases and APIs to provide options for patients who need them.

These PCCA formulas are backed by solid science. They have gone through and passed stability-indicating testing and are denoted in our database with the “BUD Study” designation in the title and accompanied by the FormulaPlus symbol: . Stability-indicating testing methods are so precise that they are capable of not only detecting the specific API in the preparation, but also the presence of other substances, such as impurities, degradation products and excipients, and clearly differentiating between all of them to provide an incredibly precise measure of the potency of the API over time, thereby verifying the stability of the preparation.

Benefits of FormulaPlus Formulas

Lower operating costs by allowing prolonged BUDs without having to spend thousands of dollars on stability testing
Increased operational efficiency by granting extended BUDs for compounders making anticipatory batches

These allow you to use a single formula to create a number of compounds with extended BUDs as long as the API in each compound is within the range of strengths listed in the formula. For bracketed formulas, we use a stability-indicating assay to test the potency of the low concentration and the high concentration of the API(s) in the formulation over time. This establishes the potency over time of the entire range of strengths for the API.

9400+

Proprietary formulas that help achieve positive, reproducible results for patients.

Over the years, our Formulation Development department has created formulas using our exceptional ingredients and industry-defining bases at the request of PCCA members and our Clinical Services department. Formulation Development has also created them to support new PCCA bases and ensure that our members have what they need to start using those new vehicles.

140+

FormulaPlus^™ formulas with extended beyond-use dates (BUDs).

These PCCA formulas are backed by solid science. They have gone through and passed stability-indicating testing and are denoted in our database with the “BUD Study” designation in the title and accompanied by the FormulaPlus symbol: . Stability-indicating testing methods are so precise that they are capable of not only detecting the specific API in the preparation, but also the presence of other substances, such as impurities, degradation products and excipients, and clearly differentiating between all of them to provide an incredibly precise measure of the potency of the API over time, thereby verifying the stability of the preparation.

Benefits of FormulaPlus Formulas

Lower operating costs by allowing prolonged BUDs without having to spend thousands of dollars on stability testing
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Bracketed formulas with extended BUDs.

These allow you to use a single formula to create a number of compounds with extended BUDs as long as the API in each compound is within the range of strengths listed in the formula. For bracketed formulas, we use a stability-indicating assay to test the potency of the low concentration and the high concentration of the API(s) in the formulation over time. This establishes the potency over time of the entire range of strengths for the API.

Blue Box Note

In all PCCA formulas, we include a statement enclosed in a blue text box. It indicates that using ingredients other than the ones listed in the formula may negatively affect the resulting preparation and will invalidate the BUD shown in the formula.

This statement is not arbitrary. Rather, there is sound scientific reasoning behind it: We don’t know the important functional and physical attributes of other chemicals that pharmacopeial standards may not account for, and that may impact how those chemicals behave in formulations. We also don’t know the specifications of other chemicals and bases, nor what their repackaging processes and containers are, among other variables that can affect chemicals and their stability over time.

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When you purchase compounding ingredients from PCCA, The PCCA Standard is your competitive advantage.

Here are links to some tools you can use to share this difference with prescribers and patients:

Postcard for Prescribers — PCCA Member Resource
In-Store Monitor Graphic 1 — PCCA Member Resource
In-Store Monitor Graphic 2 — PCCA Member Resource
The PCCA Standard Overview Video
"The New Way of Talking about Quality: The PCCA Standard" v2ray手机版下载
"5 Tips for Talking to Prescribers about Quality" on The PCCA Blog
Episode 18: "PCCA Innovation with Gus Bassani" on The Mortar & Pestle podcast

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The PCCA Standard is, above all, our commitment to making the hard choices about the products and support we provide you and, ultimately, your patients — making those hard choices so that you don’t have to.

Accessing the highest quality is an easy choice

The highest quality is an easy choice

Copyright © 2023 PCCA. All rights reserved.

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