Quality, safety and regulatory · Batch release
“Batches pile up before release because reviewing the data takes days every time.”
Clear the batch release backlog: review release data
Before your QP releases a batch, results have to be checked against specification, trend and process capability, and that is exactly where the backlog builds up. CovaSyn evaluates your release data across all batches, flags deviations, trends and rule violations and calculates process capability. You receive an overview with justification that your QP reviews and uses for release.
Starting point
When you need this
- Finished batches wait for release because data review cannot keep up with production.
- A result is within specification but close to the limit, and nobody knows whether that is already a trend.
- The annual product quality review is due, and the trend evaluation for the year is missing.
- A sponsor or auditor asks for Cpk and control charts for the critical quality attributes.
If nothing changes
What it costs when the case stays open
- Batches sit in the warehouse instead of at the customer, and delivery dates slip.
- A creeping trend is noticed only when a batch falls out of specification and is blocked.
- Missing trend evaluation in the product quality review becomes an audit finding.
Result
What you get
Check against specification
Every release result against its limits, with results close to the limit flagged separately.
Control charts and trends
Control charts for the critical quality attributes across all batches, with rule violations and shifts shown before they become a deviation.
Process capability Cpk and Ppk
Process capability per attribute with a check of the distribution, so you know how reliably your process meets the specification.
Overview for release
An overview per batch and for the period, with input data and justification, which your QP reviews and takes into release or the product quality review.
How it works
From an open case to a signed-off report
1. Describe the case
In the initial call, 30 minutes on Microsoft Teams. We tell you honestly whether we can solve your problem.
2. Send the data
Confidential from the start. We run the evaluation, typically within 5 working days once we have your data.
3. Sign off the report
You receive the result with reasoning and input data. Your expert reviews and approves it.
CovaSyn
What we evaluate for this
Every number is calculated, not estimated. Every evaluation is documented with its input data and reasoning, so your expert can review and sign it off.
Control charts with rule violations
Control charts for individual values and trends, with the usual rules for outliers, runs and shifts.
Process capability calculated
Cpk and Ppk per attribute, with a check of whether the data supports the calculation.
Trend and OOT detection across all batches
Unusual results are checked against the course of comparable batches, not only against the specification.
Audience
Who it is for
For QA, QPs, QC and production management at drug product and API manufacturers and CDMOs where reviewing release data has become the bottleneck.
What the computation does not replace
- Releasing a batch remains your QP's decision. The evaluation prepares it and does not replace it.
- Process capability only becomes reliable with a sufficient number of batches. With few batches we state the uncertainty.
- We evaluate the data you provide. Completeness and correctness of the raw data stay in your system.
Insights
Read on
Cpk vs Ppk: In Control Is Not the Same as Capable
Process capability for pharma: what Cpk and Ppk actually measure, why a stable process can still miss target, and a worked example with real SPC.
Read articleOOT vs OOS in Stability Data: Catching Drift Early
Out of trend stability data explained: how OOT differs from OOS, when regression, CUSUM and Shewhart methods fire, and a worked example.
Read articleUV Dissolution Testing: f2, Sink Conditions, Limits
UV dissolution testing end to end: calibration, ICH Q2(R2) validation, f1/f2 similarity, sink conditions, and where UV loses to HPLC, with a worked example.
Read article
Questions
Common questions
How can the batch release backlog be reduced?
Most of the time usually goes into reviewing results against specification and trend. When that review is prepared and anomalies are already flagged, your QP can concentrate on the points that really need a decision.
Which control charts suit release data?
For single results per batch, individuals and moving range charts are common. What matters are rules that detect not only values outside the limits but also runs and shifts that announce a trend.
What Cpk is sufficient in pharmaceutical manufacturing?
A Cpk of at least 1.33 is often used as the target for a capable process, and more is often expected for critical attributes. More important than the number is whether the data is stable and approximately normally distributed, otherwise the value is not meaningful.
Does the evaluation also help with the product quality review?
Yes. Trends, control charts and process capability over the review period are core parts of the product quality review. CovaSyn delivers this evaluation with justification, so your QA can take it over.
Who can review our release data?
CovaSyn does this as Done-for-You: you describe product and data in the initial call, we agree on scope, and you typically receive the evaluation within 5 working days once we have your data. Handled confidentially from the start.
Quality, safety and regulatory
Related problems we solve
Extractables and leachables assessment: identification to toxicology
The extractables study produced a long peak list, and for most peaks we have neither a name nor an assessment.
See solutionForced degradation study: degradation products and mass balance
The mass balance in our stress study doesn't close, and we don't know where the missing part went.
See solutionNitrosamine risk assessment: identify and justify NDSRIs
The authority wants to see our nitrosamine risk assessment, and we don't know whether our API can form an NDSRI.
See solutionStability data evaluation: detect OOT and estimate shelf life
One result in our stability study looks different from the earlier ones, and we don't know whether it's a trend or just scatter.
See solutionClose OOS investigations faster and audit-ready
We have an OOS result, the batch is on hold, and the investigation hasn't reached a conclusion for weeks.
See solution
Next step
Tell us about your release process.
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.