Regulatory guidelines by Medicines and Healthcare products Regulatory Agency- UK MHRA including GMP - Orange Guide, Validation, GLP pdf format. Full form of MHRA is Medicines and Healthcare products Regulatory Agency. The companies those comply their GMP regulations can. The Orange and Green Guides are almost ready for publication. 16 of GMP; and; MHRA Data Integrity definitions and guidance for Industry. Order before 31st December using code MHRA17 to receive free postage. Approved Drug Products – Orange Book 37th Edition. July Download. Orange Book – 37th Edition. Adobe Acrobat.

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MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March Page 1 of .. Reconciliation, or the use of controlled books with. This is the tenth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide. The Orange Guide (Rules and Guidance for Pharmaceutical Mark Birse, Group Manager in MHRA 's Inspection, Enforcement and Standard.

Records of manufacture including distribution that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form. Any distribution of products must minimize any risk to their quality.

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A system must be in place for recalling any batch from sale or supply. Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence. Good manufacturing practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing quality products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements.

It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. The regulations use the phrase "current good manufacturing practices" CGMP to describe these guidelines. Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly.

Additionally, many countries perform pre-approval inspections PAI for GMP compliance prior to the approval of a new drug for marketing. An adverse drug reaction is not considered as valid if it is missing one or more of the above pieces of information. MAHs often have different processes in place for case reports that do not have an identifiable patient, reporter, drug or reaction, such as not forwarding these from local affiliates to central processing centres for inclusion in the pharmacovigilance system.

MAHs should, therefore, consider carefully the best way to capture such data so that they are available for consideration when performing signal generation activities, including when re-evaluating risk—benefit at the time of PSUR production. A reportable adverse reaction is defined as a report that contains all the elements required for a suspected adverse reaction and also meets the legislative requirements for reporting to a Competent Authority. Of the reportable adverse reactions in set D, some are also valid adverse reactions set C, see above , but some would be classified as not valid; for example, consumer reports may be reported in a PSUR but are not classified as valid as they do not contain an identifiable HCP reporter.

Owing to the large degree of intersection between the reportable and valid sets, they have been presented in the figure as merging into one another.

Within this category, there are subsets for expedited and periodic reports and the sets required for different authorities; however, these are not represented in Figure 2.

Pharmacovigilance data may move between these sets or definitions as detail is collected over time, or during assessment. For example, followup information that a patient was hospitalised for a valid adverse reaction previously regarded as non-serious could mean that the case now meets the requirements for regulatory reporting and is reclassified as a reportable adverse reaction. Alternatively, confirmation that the event occurred before the product was administered would reclassify the valid adverse reaction as a pharmacovigilance datum.

SYSTEM A system is the combination of people, processes, procedures and technology used to accomplish a set of functions. The technology used, be it paper, computer, a hybrid of paper and computer or other, is not a defining factor. As such, computer systems are a subset of all systems. It should be stressed that this system should allow for the collation of suspected adverse reactions on a global basis, where applicable. It is acceptable for there to be systems in place that are used to record information on a local basis.

However, there should also be a global system in place that includes data from all markets should the product be marketed by the MAH in countries other than the UK.

This system should be designed such that all notifications that contain pharmacovigilance data are recorded appropriately and transferred from the person receiving them e.

This transfer must happen in a timely manner so that reportable adverse reactions are notified to Competent Authorities in the correct timeframe Section 3. When transferring a pharmacovigilance datum report, it is considered good practice to include the source data, or an image of the source data.

Examples of source data include letters, emails or records of telephone calls to the company from HCPs or consumers that include details of an event. Compliance with applicable data protection requirements must be ensured when transferring data. Personnel within the pharmacovigilance function must maintain adequate records of all pharmacovigilance data received. This is appropriate for both internal transfers, such as that between the medical information and the pharmacovigilance departments, and external transfers, such as that with licence partners.

In order for reconciliation to occur, both the originator and the recipient should use unique identifiers to track every transaction. Confirmation of receipt can be done on a case-by-case basis or periodically. The latter may be more appropriate when larger numbers of cases are involved. Caution should be exercised when using automatic reply systems such as email delivery notifications. Just because an email has been delivered does not mean that someone has read it and dealt with it appropriately.

In addition to the above, the term reconciliation is used to refer to the concept of ensuring that all appropriate information has been correctly identified and transferred: for example a check that all pharmacovigilance data from product technical complaints or medical information enquiries have been appropriately recorded in the pharmacovigilance system.

This can be achieved by undertaking periodic checks of information, including correspondence files, line listings or database reviews. The MAH should define the periodicity of such checks.

Where samples are used rather than a review of a complete set, the sample size should be justified. When undertaking a review of, for example, product technical complaints to ensure that all pharmacovigilance data have been identified, do not only check those complaints that have already been categorised as such, as this will not include notifications that have been incorrectly classified in the first place.

Such a review would fail to identify these data and ensure they are reported to the pharmacovigilance system.

If no notifications have been received during the review period, it is good practice to document this fact. This provides evidence that reconciliation activities are being performed. If problems are noted during reconciliation activities, for example pharmacovigilance data that have not been identified and transferred to the pharmacovigilance system or transfers that have not been successfully received, some form of root-cause analysis should be performed to identify the reason for the failure and to identify the corrective actions that need to be put in place to prevent recurrence of the error.

This may necessitate a retrospective review of all available notifications to identify any other pharmacovigilance data that have either not been identified or not been transferred correctly. This will allow an MAH to establish whether the failure was a random error or a systematic error that requires corrective action.

Corrective action could take the form of additional training for staff to remind them of what information needs to be transferred and the process for doing so. A MAH should consider the potential mechanisms for duplicate generation and the appropriate points in their system to detect them. If duplicates are identified, analysis of the root cause should be performed and corrective action taken, if appropriate.


When duplicates are detected, one of the cases becomes the master case and retains its classification e. Additional details contained within the duplicate reports should be integrated into the master case, and the master case should then be used for all subsequent pharmacovigilance activities, such as expedited and periodic reporting.

Case reference numbers previously assigned to cases that subsequently merged with a master case should not be reused. When duplicate cases have been identified, it is useful to include a comment in the case narrative to that effect Section 3. Immediate access, for example less than one hour, should be possible for a summary of information including, at a minimum, the unique case number, suspected product, event term and narrative.

Full details of a case including source data should be quickly available, for example in less than three days. The need for cases to be accessible may be driven by the experience of a single case or a potential signal of multiple cases.


In terms of individual case reports, appropriate follow-up should be performed on all initially received pharmacovigilance data to gather sufficient information to classify them correctly to one of the more specific sets Section 3. Routinely, follow-up should not be requested for reports provided by the MHRA.

However, the MHRA will automatically send follow-up information if volunteered by the initial reporter. All attempts to perform follow-up should be recorded within the case file irrespective of whether a response was obtained or not.

The dates when follow-up was requested or received should also be recorded appropriately. Both expedited individual cases and periodic reports submitted to Competent Authorities must be an accurate representation of the data received and its evaluation.

If systematic changes are made to data, for example coding, de-coding or translations, the details of how the changes are made must be maintained by the MAH. The active set for providing information to requests for information is the suspected adverse reactions set. A reliable and reproducible method must be established for the accurate and timely depending on the urgency of the enquiry retrieval and output of stored data or records from the pharmacovigilance system.

The MAH should analyse the pharmacovigilance system and document what computer systems are used.

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The MAH must ensure and document that the computerised system s identified above conform to their established requirements for data completeness, data accuracy, system reliability and consistent intended performance.

The method used for documenting the requirements and ensuring conformance will depend on the criticality and complexity of the particular computer systems.

Applicable laws concerning data privacy and consequent requirements should be documented. The MAH must maintain a list of individuals who are authorised to access the system and make data changes. The MAH must maintain adequate back-up of the data. The MAH must ensure that pharmacovigilance activities can be undertaken within the required timeframe if there is disruption to the system, for example by having a business continuity plan.

The MAH must ensure that there are adequate measures in place in case of major service disruption, for example by having a disaster recovery plan.

The MAH must provide sufficient training to ensure staff competence in using the computer system and data processing for pharmacovigilance activities. The MAH must maintain procedures for using the systems.The SDS samples above are collected from the Internet by chemBlink and displayed here for the tutorial purpose only.

This may necessitate a retrospective review of all available notifications to identify any other pharmacovigilance data that have either not been identified or not been transferred correctly. Reconciliation activities between the two departments should also be undertaken Section 2.

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