Enhance quality management in the pharma industry with our APQR solution, enabling thorough evaluation of product quality data, identification of trends, and implementation of proactive measures for continuous improvement
Annual Product Quality Review (APQR/PQR/APR) Software
Every commercial product manufactured in the Pharmaceutical, API (Active Pharmaceutical Ingredient) Manufacturers, Contract Development and Manufacturing Organization (CDMO), Biotech, and Bio-sciences, Contract Research Organization (CRO) Industries undergo a Annual Product Quality Review (PQR). This requirement is published as the final current good manufacturing practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). The PQR has largely been termed ‘Product Annual Review’ or the ‘Annual Product Review’ (APQR) by FDA and within the pharmaceutical industry. The products follow the established protocols of the US FDA with GMP standards, and they are distributed within the United States markets.
The Annual Product Quality Review (APQR/PQR) was introduced as part of the GMP practices to provide manufacturers of pharmaceutical products with a set of reliable procedures. These procedures must be followed in reviewing the quality standards of every drug product. The content and management of Quality Product Reviews are to be established according to the regulatory requirements.
The Annual Product Review (APR) within pharmaceutical companies is therefore necessary for the verification of the consistency of the manufacturing procedures, examination of trends, identification of changes required in the specifications or the methods or production technique.
The guideline established in ICH Q7 2.5 Product Quality Review 2.50 states that regular quality reviews of APIs should be conducted to verify the consistency of the process. This is referred to by EU guidelines for Good Manufacturing Practice as PQR (Product Quality Review), and the processes adopted for Product Quality Review (PQR) are based on EU GMP standards.
Developed on LOW-CODE AND NO-CODE (LCNC) PLATFORM, AmpleLogic APQR/PQR Software captures information manually and collects information from other sources. It extracts this information by combining it with software systems that the company may utilize. LMS, QMS, BMS, and MES/eBMR are examples of these software systems. The Product Quality Review (PQR) System may also collect data from a range of different software systems and legacy products in your organization’s IT infrastructure.
Key Features of APQR and PQR Software
- AmpleLogic APQR Software auto generates APQR word document for every product manufactured as per the predefined template based on the selection of the start and end date.
- Teams can generate the Product Quality Review (PQR) at any time based on the period of selection.
- Provision of auto alerts for delays beyond seven days.
- The APR (Annual Product Review) Software manages the master data for all parameters along with limits like NLT and NMT.
- It provides statistical analysis and trends on Assay, Water Content, PH, Specific Impurities, and Total Impurities.
- It creates reports on batch-wise trends to track granulation yield, compression yield along with coating and packing yield.
- This Annual Product Review System can generate a six-pack report with performance indices of 3 Sigma or 6 Sigma.
- The APR Software program provides an organization with easy access to dashboards that provide intelligence regarding trends of each in-process parameter. Information is also captured along with a lower and upper limit.
- Users can auto version of the PQR document.
- The AmpleLogic PQR Software provides trends related to Analytical Parameters and Stability Trends.
- Validation color will be indicated in the PQR System if any out of limit entered by the user.
- This Electronic PQR Software will auto-calculates the Mean, Median, and Standard Deviations.
- There is also auto generation of Process Capability (Cp), CPK (Process Capability Index), Process capability Upper limit (CPU), Process capability Lower Limit (CPL), Upper Control Limit (UCL), Lower Control Limit (LCL) and Standard Deviations by using the R-Tools and R-Studio.
- The Product Quality Review Software will allow the generation of the quality review for any period. It can also generate a comparison between two different periods.
- This Electronic APQR System can generate various trend reports of yield, critical process parameter, In-process quality parameter, and other required reports.
- By integrating with R-tools and R-Studio, APQR Software System will be able to generate the control charts I Chart, Normal Probability Plot, moving range chart, Process Capability Analysis and last 15 observations will be shown, where variation of a parameter across different batches can be seen.
The APQR System complies with all major standards including 21 CFR PART 11, MHRA, and EU Annex 11 Standards.
AmpleLogic Product Quality Review Solution conforms with electronic record standards set by the TGA, CDSCO, HEALTH CANADA, the MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, among other regulatory agencies
Key data captured in AmpleLogic Product Quality Review Software
- The Annual Product Review (APR) software collects batch information such as product code, shelf life, date of production, and date of expiration, as well as pack size. Information on process yields such as granulation, compression, coating, and packaging are also captured.
- Other information like raw material, packaging materials, batch failure or batch Rejections, deviations, are captured.
- It provides information on process control and analytical test results
- In Process Parameters for Granulation, Compression, Coating, and Packing Processes
- Out of specification and out of trend results
- Process change requests and other types of change requests like Analytical change requests
- Information related to marketing authorization and details of market variations like changes in the label.
- Categorized month-wise and condition-wise details relating to the product stability
- Provision to capture both child and parent products in the generated APQR document.
- Product returns, Market complaints, product recalls
- Field alerts
- Product-Related CAPA’s
- Marketing commitments
- Information about the equipment, instruments, and utilities involved in the manufacture of the product including their qualification status. These include HVAC, water, and compressed gas.
- Details from Building Management Systems namely temperature and humidity records
- Provision to convert the CPK values from 6 sigma to 3 sigma in case of any deviations
- Provides information on product quality agreement for the respective API along with details of raw materials and their suppliers.
- Continuous process verification can be done throughout the APQR system by using six pack report and Nelson’s rule to investigate about each and every batch data.
- It provides an Analytical Method Validation and revalidation of data
Other industries that can take advantage of Electronic APQR Software
- Medical Devices
- Contract Development and Manufacturing Organization (CDMO)
- Chemical Industry
- Contract Manufacturing Organization
- General Manufacturing
- Contract Research Organization (CRO)
- Food & Beverages
Kindly contact us for more information about how your organization can benefit from AmpleLogic APQR or APR Software
Process Capability Analysis (cp, cpk, pp, ppk, cpv)
Cp, Cpk, Pp, and Ppk are the most commonly used process capability indices in process capability analysis.
Amplelogic Annual Product Review (APR) software, the tool helps in Process capability analysis by taking the data from the LIMS, EQMS, Batch Manufacturing Records. The tool applies statistical methods defined in R Language to calculate the Process capability indices like Cp, Cpk, Pp, and Ppk and marks the variations.
The Product Quality Review (PQR) Software Alers the Quality teams on Process Deviations for every batch that is entered/Captured.
Triggers immediate alarms whenever CP, CPK,PP, PPK values are less than 1, System alerts with Alarms as the Process is not capable of producing parts within the specification limits.
The process of continued process verification (CPV) involves the ongoing verification of a manufacturing process’s performance. Process validation life cycle, It make sure the process remains in a validated state throughout the routine manufacturing phase of a product’s life cycle. With Amplelogic PQR software R &D, Pharmaceutical, CDMO, CRO ‘s can monitor the performance on every batch it manufactured and ensures in meeting Six Sigma standards by continuously meeting established specifications to make sure producing high-quality products.
What is PPK?
Similar to PP, if the PPK (Process Performance with a centering factor) values are less than 1 it allows the user to access the entire data and allows the Analysts to do a detailed analysis for the challenges in addressing the Process challenges
Goodness-of-fitness Test: (GoF Test)
Goodness of fitness tests are statical test methods used to determine whether a set of observed values match those predicted or fitted by the model, applied in decision making.
Initially, normality is checked by some adherence test on the original data, and if normality is not found (Non-normal data) some type of transformation is applied to thses data sets and normality is checked again. If normality is still not found, can look for another distribution that fits in the data set. The most distributions used are
Normal transformation, Box-cox transformation, Log normal, 3- parameter log normal, Exponential, 2-parameter exponential, Weibull, 3-parameter Weibull, Smallest extreme value, Largest extreme value, Gamma,3-parameter gamma, Logistic, Loglogistic, 3-parameter log logistic