In 2011 this blog was listed as one of the top 10 blog in pharma technical information it is popular amongst the pharmacists and pharma industry professionals. We have published very important and very useful information for pharma industry professionals.

Wednesday, April 20, 2011

concurrent release of PPQ batches Pharma process validation

Process validation and aspects of concurrent release of Process Performance Qualification PPQ batches.

Validation in pharmaceutical manufacturing and any of the process carried out in its process is very important factor as mentioned in current good manufacturing practices guidelines and in the guidelines on process validation published by US FDA in Jan 2011, drug manufactured in the facility not complying validations and current good manufacturing practice (C GMP guidelines) for finished pharmaceuticals are provided in 21 CFR parts 210 and 211 are deemed as adulterated even though it meets all of its standards.
Also see Pharmaceutical Validations here at  validations

In most cases, the Process Performance Qualification PPQ study needs to be completed successfully and a high degree of assurance in the process achieved before commercial distribution of a product. In special situations, the PPQ protocol can be designed to release a Process Performance Qualification PPQ batch for distribution before complete execution of the protocol steps and activities, i.e., concurrent release. FDA has stated in the guidelines on process validation published by US FDA in Jan 2011 that they expects that concurrent release will be used rarely.
Concurrent release might be appropriate for processes used infrequently for various reasons, such as to manufacture drugs for which there is limited demand (e.g., orphan drugs, minor use and minor species veterinary drugs) or which have short half lives (e.g., radiopharmaceuticals, including positron emission tomography drugs). Concurrent release might also be appropriate for drugs that are medically necessary and are being manufactured in coordination with the Agency to alleviate a short supply.

Conclusions about a commercial manufacturing process can only be made after the PPQ protocol is fully executed and the data are fully evaluated. If Stage 2 qualification is not successful (i.e., does not demonstrate that the process as designed is capable of reproducible performance at commercial scale), then additional design studies and qualification may be necessary. The new product and process understanding obtained from the unsuccessful qualification study(ies) can have negative implications if any lot was already distributed. Full execution of Stages 1 and 2 of process validation is intended to preclude or minimize that outcome.

Circumstances and rationale for concurrent release should be fully described in the PPQ protocol. Even when process performance assessment based on the PPQ protocol is still outstanding, any lot released concurrently must comply with all CGMP guidelines, regulatory approval requirements, and PPQ protocol lot release criteria. Lot release under a PPQ protocol is based upon meeting confidence levels appropriate for each quality attribute of the drug.
When warranted and used, concurrent release should be accompanied by a system for careful oversight of the distributed batch to facilitate rapid customer feedback. For example, customer complaints and defect reports should be rapidly assessed to determine root cause and whether the process should be improved or changed. Concurrently released lots must also be assessed in light of any negative PPQ study finding or conclusions and appropriate corrective action must be taken (§§ 211.100(a), 211.180(e), and 211.192). We recommend that each batch in a concurrent release program be evaluated for inclusion in the stability program. It is important that stability test data be promptly evaluated to ensure rapid detection and correction of any problems.
GMP guidelines
Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical product to foreign countries

Process Validation guidelines Series    

Process validation aspects of Analytical Methodology.

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations

You may also like

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables

What is an Isolator in pharmaceutical manufacturing

What is a Laminar Air Flow Cabinet?

21 cfr part 11 FDA guidelines .

Validation In pharmaceutical

Media Fill Run To Ensure Sterility In Sterile Dosage Forms

What is HEPA filter?

Clean Room Classification

Pharma sales jobs Find best Jobs for Pharmacists

Details on pharmaguideline. are here at who guideline blogspot com(

No comments:

What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.

What is a Site Master file of a pharmaceutical company

What is Generic Drug

What is Reference Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents

What are Post Market studies

Why a drug is bound to protein, What is protein binding?  What is drug absorption , distribution ?

Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions

Antibiotic Definition and classification

Antibiotic Resistance and Antibiotic resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production


Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials




Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs


Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates