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PIC/S GMP Evidence & Implementation Kit

$249.00
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PIC/S GMP · Good Manufacturing Practice · Evidence & Implementation Kit
Meet the PIC/S GMP guide, without turning the chapters into a program yourself.
Every requirement handed to you as an adopt-ready control, from the quality system and validation through production and quality control to batch release, outsourcing and self-inspection, with the evidence an inspector examines.
Inspection-ready in a weekend, not a quarter.

Here is the honest situation. The PIC/S GMP guide sets the standard for manufacturing medicinal products: a pharmaceutical quality system with risk management, qualified personnel, qualified premises and equipment, validated processes and systems, controlled documentation with data integrity, controlled production and quality control, batch release by the authorised person, and self-inspection. A manufacturer that runs a clean operation but cannot show its validation, its data integrity or its batch release is exactly where manufacturers fall short in an inspection.

This Kit removes the guesswork. It is the PIC/S GMP guide written as adopt-ready controls you personalize in a weekend, with the evidence an inspector examines.

What you get, the moment you buy

18
Requirements as adopt-ready controls. Every requirement, from the quality system and validation through production, quality control, batch release, outsourcing and self-inspection, written so you personalize and apply it.
18
Evidence-they-examine checklists. For each control, exactly what an inspector examines, plus where manufacturers fall short, so you close the gap first.
1
GMP Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record status, owner and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook returns your readiness as a single percentage, and exactly what to fix before an inspection.

Grounded in the PIC/S GMP guide, with the pharmaceutical quality system and risk management, personnel, premises and equipment, validation, documentation and data integrity, production and quality control, batch release, outsourcing, complaints and recall and self-inspection called out. Editable Word and Excel files.

Data integrity and batch release are the inspection focus
GMP inspections dig into data integrity across records and into batch certification by the authorised person. A manufacturer with a tidy plant but weak audit trails or informal release decisions gets findings. This Kit builds the quality system, validation, data integrity and release controls with the evidence an inspector asks for.

What one control looks like

This is operating a pharmaceutical quality system, where GMP begins. All 18 are built to this depth.

PICS-1 Operate a pharmaceutical quality system QUALITY
Put this control in place

Establish and maintain a pharmaceutical quality system at [your organization name] that ensures medicinal products are consistently produced and controlled to the quality required for their intended use, covering GMP, quality risk management and product quality review, and document it, so that quality is managed systematically and the organization can evidence its pharmaceutical quality system against the PIC/S GMP guide.

Guide note.

The PIC/S GMP guide requires an effective pharmaceutical quality system underpinned by quality risk management.

Evidence an inspector examines
  • The pharmaceutical quality system
  • Quality risk management
  • Product quality review
Common finding they raise: Products are manufactured with no pharmaceutical quality system.

Why this is not another template pack

  • The evidence is the point. A requirement you cannot evidence is an inspection finding that can stop supply. This tells you what an inspector examines and where manufacturers fall short, for every requirement.
  • Quality system, validation and release built in. The quality system, the validation, the data integrity and the batch release are written into the controls, the substance the GMP guide requires.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. PIC/S GMP aligns with 21 CFR Part 11 and your wider quality systems, so this work feeds your broader pharmaceutical compliance.

Who buys this

Pharmaceutical manufacturers and their quality assurance, quality control, production and regulatory leads. Whether it is a first alignment or an inspection-readiness pass, you save weeks and walk in with the quality system, validation, production, quality control and release structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 18 requirements
✓  A completed GMP control matrix
✓  The evidence an inspector examines
✓  Your quality system and validation in place
✓  A readiness percentage and a fix list
✓  The data integrity and release gaps closed

Common questions

Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.

Is this the GMP certificate itself? No. It is an implementation toolkit grounded in the guide. Certification and inspection are by the authority; this gets your quality system and evidence in order fast.

Does it cover data integrity? Yes. Data integrity across paper and electronic records is built as a control.

Does it cover batch release? Yes. Batch certification and release by the authorised person is built as a control.

What if it is not for me? A 30-day money-back guarantee.

Do not release product you cannot show was made to GMP.
Every GMP requirement is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be inspection-ready this weekend.

Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com

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