7 Objectives

7 Objective for Regulatory Streamlined Approach for Pharmaceutical Manufacturing Facilities & Equipment (21 CFR Part 211).

Hello Everyone,

Welcome to Pharm grip.

Let’s go through the 7 Objective for Regulatory Streamlined Approach for Pharmaceutical Manufacturing Facilities & Equipment (21 CFR Part 211).

in this article, I am sharing the outlines of how to follow the best Regulatory cGMP requirements for implementing the best Design, Qualification & Validation of Pharmaceutical Equipment & facilities.

Our main reference will be US-FDA requirements as stated in 21 CFR Part 211 (Facilities & Equipment) I need to focus on an important issue,

USFDA Regulations may not provide detailed design requirements for pharmaceutical Facilities & Equipment USFDA

Just legislates requirements without go beyond this and discuss technical aspects in details consequently,

Our intent for this article is to go in-depth and discuss detailed-design for pharmaceutical facilities and equipment.

This will be discussed based on practical experience along with citations quoted from supportive references Before going further step,

Let’s discuss the scope of discussion for this regulatory requirement (21 CFR Part 211)

Let’s have a look at this section (21 CFR Part 211),

Subpart A: General Provisions

Subpart B: Electronic Records

Subpart C: Electronic Signatures

Subpart D: Equipment

Subpart E: Control of Components and Drug Product Containers and Closures

Subpart F: Production and Process Controls

Subpart G: Packaging and Labelling Control

Subpart H: Holding and Distribution

Subpart I: Laboratory Controls

Subpart J: Records and Reports

Subpart K: Returned and Salvaged Drug Products

Subpart L: Foreign Supplier Verification Programs for Food Importers

Subpart M: Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications

We notice that it contains different sections but this article will focus on Section C (Buildings & Facilities) Furthermore, focuses on Section D (Equipment).

Let us now discuss the 7 main objectives for this article.

7 Objective for Regulatory Streamlined Approach for Pharmaceutical Manufacturing Facilities & Equipment (21 CFR Part 211).
7 Objective for Regulatory Streamlined Approach for Pharmaceutical Manufacturing Facilities & Equipment (21 CFR Part 211).

FIRST OBJECTIVE:

Take idea about cGMP design requirements for the facility and gives live examples for each regulatory aspect during a discussion of this objective,

We want to introduce each Regulatory Requirements which are relevant to pharmaceutical buildings and facilities (as legislated in USFDA) Furthermore,

We going to discuss how we can implement these regulations on the ground as we know,

There are some cross-functional activities, whatever, Engineering or Quality related aspects

We will give an idea of how these aspects are correlated with each other for the sake of product’s quality (as called: successful implementation of Cross Functioning Activities) for

SECOND OBJECTIVE:

Take Idea about cGMP design Requirements for the Equipment and gives live examples for each regulatory aspect it outlines Regulatory Requirements

Which are relevant to pharmaceutical Equipment (as legislated in USFDA) Bear in mind, Equipment is the core of the pharmaceutical manufacturing process including the need to achieve

The productivity and throughput (Qualitatively and Quantitatively) In addition, we still have some challenges and debates with regulatory bodies

Where there are different regulatory requirements for this pharmaceutical equipment I need to emphasize that USDFA regulatory requirements for the equipment address general requirements and not go into details

It’s worthy to pay your attention that some equipment’s’ regulations/requirements may be the point of concern in some Pharmaceutical industry (or equipment used for specific dosage form) more than other equipment used in other pharmaceutical industry for this reason,

More details about pharmaceutical equipment are required to overcome these challenges we face and avoid debate with regulatory bodies

We can here take an idea about equipment design aspects and optimist these aspects to meet all requirements That in turn will suit the business need without adding unnecessary equipment requirements and even not an exaggeration with these requirements Concerning to

THIRD OBJECTIVE:

Take idea about cGMP key aspects related to cGMP utilities including construction, Operation, and maintenance requirements

During the discussion of this objective, a detailed explanation about regulatory & technical design requirements relevant to pharmaceutical utilities will be introduced

This includes: water treatment system Heating, Ventilation Air Conditioning System (HVAC System) Gases System Pure Steam Generation System Sewage and Refuse System Furthermost,

You will take Idea about selection Materials of Constructions (MOC) for systems to suit the intended purpose in pharmaceutical industries Moreover,

equipment regulatory requirements for the programs applied for operation, maintenance, and calibration will be introduced in this course in order to keep equipment always in a state of control Concerning to

FOURTH OBJECTIVE:

Take an idea about the design requirement to prevent the contamination/cross-contamination between rooms/zones within different functions.

It outlines some specific design specifications for pharmaceutical facilities

Where these specifications are set to prevent any external contamination ingresses to the pharmaceutical facility (called Prevention of Contamination) this contamination could result from personnel, equipment, or surrounding environment Furthermore,

This program outlines how to avoid contamination between different products (called: Cross Contamination) Prevention the Cross Contamination is the point of pharmaceutical manufacturer concern raised by regulatory bodies as a prerequisite for building supportive quality system,

Prevention cross-contamination is subjected to be proven through designing good Facilities & Equipment Concerning to the

FIFTH OBJECTIVE:

Take idea about Qualification & Validation (Q&V) activities for different Equipment and Systems for OSD facilities

It outlines the Qualification & Validation regulatory requirements for Pharmaceutical Facilities and Equipment.

Qualification & Validation of Premises and Equipment We may focus here on some systems used in Oral-Dosage-Forms (OSD) manufacturing facilities Concerning to the

SIXTH OBJECTIVE:

Take an idea and differentiate between cGMP and non-cGMP layouts we focus the light on some pharmaceutical layouts/ blueprints used in pharmaceutical industries

That is interested in regulatory bodies this implies the layouts that are normally requested by the regulatory inspector

This also implies the layouts that are not usually requested by the regulatory inspector, but it is necessary from an engineering point of view Availability of blueprint system in the pharmaceutical industry is very important Availability of blueprint system gives an indication that pharmaceutical manufacturer took all engineering and quality aspects for the sake of product quality This will enhance the current quality system by applying Good Documentation Practices (GDP system) Consequently,

This reduces effort and increases compliance, in addition to achieving common understandings with inspectors and without unnecessary debates or request further documents Keep in your mind that these blueprints can be as an alternative for some unnecessary documents that may be requested by the inspector the last objective we have here

SEVENTH OBJECTIVE:

The participant will be familiar with evaluation for the demands of the new production line to avoid over/underutilization

This Objective is considered important it discusses how to achieve the best capacities for equipment (Production Equipment Capacities) and finally determines the suitable size for the facility preceding investment decision is taken If over-utilized equipment was selected,

This will not be feasible and being a not a wise decision for investment If under-utilized equipment was selected, this will not be feasible to achieve on-time targeted capacity and achieve the required productivity For these two scenarios,

this will compromise the equipment productivity, in addition to other technical problems that may be raised These problems will be the point of discussions and debates with regulatory inspectors This objective that outlines utilization is considered important to be aware of by the planning department in the early phase And consequently,

Avoiding any obstacles that may be faced during pharmaceutical processes and finally get the high-quality product and achieve uninterrupted productivity finally,

I hope that we clearly explained and gave a comprehensive overview of the objectives for this article I need to emphasize again that this course gives a clear idea about vague USFDA regulations normally,

USFDA regulations do not explain in a comprehensive way and this training will give more interpretations about these CFR regulations finally,

Hopefully, it explained a clear idea about its objectives in this article 7 Objective for Regulatory Streamlined Approach for Pharmaceutical Manufacturing Facilities & Equipment (21 CFR Part 211).

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