Understanding the Pharmaceutical Batch Record Review

The pharmaceutical batch record review is a very crucial tool for ensuring both quality of the product process and compliance with regulatory requirements. It is an important means by which pharmaceutical organizations can formulate two important strategies:

  1. A pharmaceutical batch record review is a very effective medium for keeping complete track of the firm’s day-to-day operations. A pharmaceutical batch record review helps the organization track its product from start to finish, thereby leaving no scope for ambiguity or uncertainty anywhere in the chain;
  2. It helps the organization adhere in letter and spirit to regulatory requirements. Being in compliance with regulatory requirements is the surest means to avoiding collisions with regulatory authorities such as the FDA and others.


Regulatory guidelines from any regulatory body around the globe have a common requirement: that of maintenance or adherence to pharmaceutical batch record review standards if regulatory compliance is to be achieved. Review of production and quality control records are built into the approval process of a batch release. These are to be implemented at all the stages of the pharmaceutical batch record review, namely creation or alteration of master documents, along its distribution chain, records collection, and process for archiving and retrieving.

All regulatory authorities insist on the need and imperative of manufacturers to identify and exhaustively investigate the failure of a batch to meet its required specifications.

Another important requirement of a pharmaceutical batch record review is that investigation of a batch’s divergence, big or small, or inability for meeting specifications should be extendable to remaining batches of the same product, as well as related products which may have been involved in or associated with that particular failure or deviation or one similar to it. Pharmaceutical batch record review requires the organizations to write down records of the investigation and mention what corrective action was initiated, and what status this action has.

Regulations relating to pharmaceutical batch record review

All around the world, regulatory authorities have their respective regulations and standards pertaining to their requirements for meeting pharmaceutical batch record review standards. These are the current pharmaceutical batch record review standards around the globe:

  • EU Regulations
  • FDA
  • ICH Q7 requirements
  • Updates to ICH Q9/Q10 and EU-GMP Chapter 1
  • Updates to the Counterfeit Directive

Read More: https://www.linkedin.com/pulse/understanding-pharmaceutical-batch-record-review-ronald-gardner?published=t



FDA Guideline on Process Validation

FDA Guideline on Process Validation.

Process Validation (PV), as defined by the FDA, has undergone a change from the past 25 years or so. The meaning of PV is what the FDA assigns to it. So, any understanding of PV has to be tied to FDA’s guidelines which offer a definition of the term, as well as updates from time to time.

The previous and the latest guidelines…

The latest FDA guideline on PV came in 2011, and was consequential to the earlier one of 1987. In view of the changes in the industry, the definition of the scope of PV also changed. Earlier, the FDA described PV as the process of “…establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics”.

The guideline of 2011

Considering the insufficiency of this definition, the FDA issued another guideline, an updated one, in January 2011 to make the definition more wide-ranging. Expectedly, it is more comprehensive and emphasizes process understanding and control as a means of focusing on product quality. PV now means “the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product”.

How is the 2011 Guideline different?

As defined more comprehensively in the January 2011 Guideline, the following changes may be discerned from the 1987 Guideline:

• There is added emphasis on process design. Risk is now incorporated into process design

• It now covers activities ranging over the entire process lifecycle, which is an ongoing program that is carried out in three defined stages

• Greater emphasis is laid on the role of objective measures and statistical tools

• Knowledge, detection and control of variability have got a greater thrust from this Guideline.





Most Common Problems of Software Validation Processes

Most Common Problems of Software Validation Processes.

Software validation processes have always been important; yet, they acquired a special sense of urgency and added importance following the announcement in August 2010 by the FDA in this regard, in which it stated that it “…will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures – Scope and Application’ guidance (Guidance).” Why this added emphasis on action?

The FDA accentuated its action on software validation processes for two important reasons:

1) in the industry, there were diffuse and subjective interpretations about the understanding and application of Part 11

2) perceptions that this statute could have the effect of restricting the use of electronic signatures and discouraging innovation.

Following this action from the FDA; a series of problems that the software validation processes had, are coming to light of late.

So, which are the most common problems of software validation processes?

The following common problems are being observed in the industry:

• Information gone missing:

• Incomplete details in the requirements documents: This has been true especially in relation to data, key processes that go into the internal software, as well as the interactions of the software with the user

• Necessary detail not found

• Traceability: This was the most important problem found in Part 11. The traceability matrix either did not account for a traceable specification or an observation step in a test script, or was incomplete, or the trace was broken.

• Incomprehensible wording in the documentation

• Several GDP-related bungling

• Difficulty in identifying the impugned documents and records





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John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com


Statistical Considerations for ICH Guidelines

Statistical Considerations for ICH Guidelines

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.

This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

More Info Click Here

The extreme importance of Quality Assurance for Computer Systems Validation (CSV)

Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11.

Knowledge gap

Many companies have a difficulty in determining what needs to be done, to meet domestic and/or international regulations or business continuity requirements, as a result of which Quality Assurance for Computer Systems Validation becomes incomplete. On top of these, as if these issues were not enough, the FDA has escalated 21 CFR 11 inspections that include CSV, making the already difficult task of requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11 all the more complex. Something like a fifth of all incorrect Medical Device Recalls is attributed to unfulfilled Computer Systems Validation, meaning that Quality Assurance is a big casualty.

Bleak future

What does a prognosis of this scenario look like? If anything, the number of recalls and Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) due to the product’s inability to meet Quality Assurance for Computer Systems Validation is set to go up. The reason behind this outlook is that technology is advancing, which brings with it many attendant pitfalls. And, as companies consider Cloud Technologies; there are sure to be patient privacy issues such as HIPAA involved in all this.

Roll up your sleeves; get your CSV right!

The costs associated with lack of implementation of Quality Assurance for Computer Systems Validation is quite shocking. In 2013, a single incorrect implementation of Quality Assurance for Computer Systems Validation resulted in fines of up to $three billion. It is but natural that software projects that need CSV get overrun by long periods of time. Corrections required to be implemented into a system that has been issued a 483 due to Quality Assurance for Computer Systems Validation can cost a quarter of a million dollars. Imagine the sheer amount of money needed when multiple issues are found.

Yet another critical reason, for which Quality Assurance for Computer Systems Validation has to be met, come what may, is that CSV is a foundation to other discovery, development & commercialization of products. So, not meeting Quality Assurance for Computer Systems Validation can result in a spiral: all the concomitant and ensuing efforts go waste.

All of this means that the need to meet Quality Assurance for Computer Systems Validation could not be more urgent or important.



Batch manufacturing record in pharmaceutical industry

A batch manufacturing record in pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of every product. The FDA defines a batch thus: “A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture”.

System of checkpoints

In the light of this definition, batch manufacturing record in pharmaceutical industry has to be understood as one that is basically based on the master formula record. It is created, checked, ratified and sanctioned by the designated, competent technical person/s that is responsible for the organization’s production and quality control.

In order to avoid wrongful reproduction, batch manufacturing record in pharmaceutical industry involves use of methods such as photo reproduction.

What should go into it?

A typical batch manufacturing record in pharmaceutical industry ideally consists of these details:

  • The product name
  • Its batch number
  • Date on which significant intermediate stage were commenced and completed
  • The name of  the person who is responsible for each stage of production
  • Initials of both operators who carried out significant processes and the persons who checked these
  • Details such as the quantity, batch number, quality control report number of each ingredient actually weighed, along with the amount of any recovered material that may have been added
  • Details of in-process controls, their results and signature of person who performed these
  • Whenever variation that exceeds expectation is observed, batch manufacturing record in pharmaceutical industry should make note of the theoretical yield and actual yield at every appropriate stage of production. These should be accompanied by an explanation
  • Details of authorization of any deviation, if any was made






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