Saturday, 7 August 2021

cGMP vs GMP | The difference You need to Know

cGMP vs GMP | The difference You need to Know


To be precise there is not much of difference between GMP and cGMP, GMP (God manufacturing Practices) stresses on the use of QMS and Hygienic Practices while manufacturing of product and with an extra “C” (Current) cGMP stresses to use updated and current guidelines with GMP.

To understand where the regulations come from, who has enforcement authority, and why you need to comply

To understand the “Fundamentals”, “Benefits” and “Key Parts” of cGMPs

What are cGMPs?

Current Good Manufacturing Practices

Come from the Food Drug and Cosmetic Act

Rules set up by the FDA that drug manufacturers need to follow in order to ensure that a safe and effective product is manufactured

Why GMP?

Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality

GMP applies to both Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs)

Fundamentals of cGMPs?

Quality Control, safety, and effectiveness must be designed and built into the product

Quality cannot be inspected or tested into a finished product

Each step of manufacturing must be controlled to maximize the chances that the Finished Good will be acceptable

What are the Benefits of cGMPs?

They outline a Quality System that reduces or prevents errors

Ensures products are safe for use in humans

Prevent/control contamination and cross-contamination

Minimizes variations in potency of the drug

Ensures reproducible physiological activity

Prevent side effects and toxicity due to variations in drug content and potency

Prevents mislabelling and adulteration

Good Manufacturing Practices

Quality assurance

Sanitation and hygiene

Qualification and validation

Product recalls

Contract production and analysis

General

                The contract giver

                The contract accepter

                The contract

Self-inspection and quality audits

                Items for self-inspection

                Self-inspection team

                Frequency of self-inspection

                Self-inspection report

                Follow-up action

                Quality audit

                Suppliers’ audits and approval

Training

Building and Facilities

                General

                Ancillary areas

                Storage areas

                Weighing areas

                Production areas

                Quality control area

Materials

                Starting materials

                Packaging materials

                Intermediate and bulk products

                Finished products

                Rejected, recovered, reprocessed and reworked materials

                Recalled products

                Returned goods

                Reagents and culture media

                Reference standards

                Waste materials

                Miscellaneous Equipment

Documentation or Records

Documents required:

Labels

Testing procedures

Specifications for starting and packaging materials, for intermediate and bulk products and for finished products

Master formulae and Batch Processing Records

Packaging instructions and Batch Packaging Records

Standard Operating procedures (SOP's) and records

Logbook

Key Parts of cGMP’s

Subpart A: Organization and Personnel 

Subpart B: Buildings and Facilities 

Subpart C: Equipment

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

Subpart E: Production and Process Controls

Subpart F: Packaging & Labelling Control 

Subpart G: Holding & Distribution 

Subpart H: Laboratory Controls

Subpart I: Records & Reports 

Subpart J: Returned & Salvaged Drug Product

CGMP REGULATION

Cover street clothes that contain contaminants, organisms you collect on your way to the plant. Cover your exposed skin which sheds particles with germs. Cover your hair which have dust & germs. Prevent hair from falling into the product. Cover the nose and mouth which are natural reservoir of germs. Trap particles or droplets from the nose and mouth Street shoes contain germs from the soil and dirt we stepped on, so it must not be worn inside the plant, plant shoes must be used instead. Cover finger nails and hands which have germs

Buildings and Facilities

Buildings must be designed with adequate size and space for operations (helps to eliminate mix-ups)

Facilities must be validated

There must be a good flow pattern for personnel, materials, products and waste materials (flow from clean to dirty)

The facility must be easy to clean and sanitize (surfaces, equipment, exposed cords, floors, ceilings…)

Environmental controls must be in place (clean rooms)

Utilities must be validated (water systems, electrical, etc.)

Must have engineering documents describing the layout of the clean rooms – controlled documents

Changes to the layout of the room after it has been validated must go through change control procedures and may require revalidation of the room

Any changes that potentially impact the ventilation in the room must be assessed for impact on the microbial levels in the room

Microorganisms, particulates, and hazardous materials must be controlled

Equipment should be selected based on the intended use and clean ability if it is to be in a clean room

Equipment must be placed in an appropriate location (temperature, humidity, etc.)

Equipment must be properly qualified (Design, Installation, Operation, Performance)

Packaging and Labelling Control

Label is a display of a written, printed or graphic matter upon the immediate container of any article

Labelling is the label and any other packaging material or container that is printed (ex. IFU, advertising materials)

Procedures must exist that document receiving, identity, storage, handling, sampling, and testing of labels and ensure that integrity is maintained throughout production and use of product

Labelling must be separated physically in storage to avoid mix-ups

Wording of labels cannot be changed unless the FDA is notified

Labelling must be inspected prior to issuing to production

All labels must be reconciled (accounted for) if not 100% inspected.

Label control begins with the design

Records and Reports

Quality Records are the proof that the procedures were followed and they show traceability of product.

Examples:

Lot History Records

Laboratory Notebooks

Protocols

Reports

Logbooks

Distribution Records

Complaint Files

Summary and conclusions:

GMP compliance is not an option

Quality should be built into the product

GMP's are very similar and are really Good Common Sense

Good Practices cover all aspects of manufacturing activities prior to supply

The role and involvement of senior management is crucial

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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