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Compliance Consultants
1151 Hope Street
Stamford CT 06907 USA
voice 203 329 2700
fax 203 329 2345
Welcome to Compliance Consultants...
...the more you learn...the more you will want us for FDA!
C2 considers that regardless which system: Good Manufacturing
Practices, Quality Systems or ISO 9000 is integrated into your manufacturing,
the ultimate goal must always remain: give the customer what is advertised and
what is expected. C2 brings both engineering {good science} and regulatory skills
{good communications}to support the analysis
and
implementation of quality systems. Our process achieves: Compliance
that is more likely achieved in in
the first round of audits, Lower
overall manufacturing costs are realized;
and Fewer
product related customer issues occur. Objective
Our process consists of an Analysis, Implementation of the
System, then maintenanceto allow easy
changes ensuring the system can be modified to represent actual activities on
the factory floor. Engineering
Tasks & Analysis Our process extends to all production issues,such as:
Specify all
components {& qualify all
vendors}; Define all
performance requirements {substances,
processes, etc.}; Optimize
batch runs, Ensure
repeatability of advertised product,
Establish
performance dynamics; and Devise a
manufacturing process that best suits
all final components. Management
responsibilities Quality Policy, Organization, Responsibility and Authority, Verification Resources and Instruction, Management Representative, Management Review, Quality in design, Documentation requirements, Purchasing, Product traceability, Quality in production, Inspection and testing, Calibration, Audits, Statistical techniques, Non-conformance, Handling and storage, Training and servicing, Quality costs, Product safety, Remedies. Contract
Review Requirements Resolving Differences Contractual Capability Records Sales Purchase
Order This verifies the authenticity of the sale. Design Control Design Controls are the single most recent addition that
caused GMP to become Quality Systems. The FDA extended their control to include
design as well as manufacturing. In our analysis we cover: Design and Development Planning Specifications/Design Inputs and Outputs Design Verification/Design Reviews Failure Modes Effects Analysis & Reliability Assessment Parts & Materials Quality Assurance Software Quality Assurance Design Transfer/Certificate/Release Documentation/Design History Record ISO Assessment and FDA Inspection Design and Development Planning Activity
Assignment Organizational
and technical Interfaces
Design
Input Design
Output Design
Verification Design Changes Purchasing General
Information Assessment
of Subcontractors Specifications
to define/ control Subcontractors Purchase
Order Verification
of Purchased Product Purchaser
Supplied Product Document
Control Analysis of requirements Planning documentation Developing precise communication Writing work instructions, policy statements and procedures The Need For Documentation benefits the
Standard Identifying the Documentation what is
documentation the
structure of documentation physical
format documentation
control Compiling the documentation Analyzing
requirements Getting
started Compiling Procedures Writing Work Instructions Standard Forms In-House National and International Standards Archival Document Control Publishing /Issuing Document Identification
and Traceabilty Process
Control General
Information Special
Procedures Traceability - Relate purchased parts to kitted parts -
production Batch, serial #’s, customer. Inspection and
Testing Receiving
Inspection and Testing In Process
Inspection and Testing Final
Inspection and Testing Inspection
and Test Records Inspection Measuring and Test equipment Calibrated
Equipment Test
Hardware Inspection
and test Status Control of
Non-Conforming Product Review and
Disposition, Material
Review Board, Dedicated
Stock Room. Corrective
Action Investigation
Analysis Preventative
Action Control Recording
of Procedures Changes Handling
Storage Packing and Delivery General
Information Handling Storage Packaging Delivery Records Indexing
Filing and Storage subcontractor
Records Internal
Quality Audits How Internal Audits Maintain Control of System Basic Philosophy of Assurance vs. Inspection Interaction of Different Requirements The Audit Cycle The audit system Audit program Formatting an Audit Plan Process
Breakdown Strategy Checklists Attributes
and Practices Questionnaires and Checklists Methods of Getting Information Recording Objective Evidence Categorizing of Non-Compliance Human Aspects of Auditing Status and Importance Follow up Actions Training Servicing Statistical Techniques Process Capability Process breakdown Audit environment Strategy Checklists Attributes and practices Non-conformities Categories Recording Evaluation Reporting the audit Corrective action Post activities Follow up Quality Systems & EN/ISO Quality Standards Scope of GMP and EN 2900/ISO 9001 Management Responsibility Production and Process Controls Design Controls/Design History Record Documentation and Quality Records Inspection and Testing Nonconforming Components and Devices Corrective Action Device Master Record and Device History Records Packaging and Labeling Control Product Identification and Traceability Complaints/MDRs/Servicing Purchasing/Handling/Storage/Distribution Training/Personnel Requirements Calibration Medical Device Directive Software Quality Assurance The FDA Inspection QA Manual The QA manual declares and calls into existence these
functions and describes their activities in the company: Role QA Declare
Activities Define
Forms Master
Device Record Responsibility
Organization
Report Role -
Mfg., Eng., Mfg Customer Life Cycle Critical Inspection Proceed Mfg
- Move MRB Training Forms
Definitions Employee
Affirmation Define
Remedies content, structure elements of
a quality system addressing
the clauses Approval
and Issues Changes and
Modifications Procedures identifying
document requirements planning Employee
Handbook for Production Assembly
Procedure Methods
Brochure, Drawings Move
Tickets Inventory
Control-Batch Kitting Run Control
MRB-rework/shrinkage/reject
Part Number
Storage Assignment Device Master
File Configuration
Parts List indicate serialized/batched
parts ECNs Drawings to
Define Build Procedure
Spec. -
source control Inspection Certification
of Compliance 510K Letter
Device
Listing User Manual
Labeling Testing,
Production Testing,
Design Performance (Weight) Calibration
Certificate of Compliance/Receiving Report Certified Test Sets Calibration Standards Incoming
Inspection Plan Define critical parts for product. Incoming Final Test Data
Records Collect all test results for incoming inspection,
performance test and final inspection. Training Skills -
Defines personnel responsibility & training
required. Log -
Tracks personnel & training required.
Remedies
Product/Recall/Failure Field Analyze Scenarios Identify Quality Problems Write Non-Compliance Analyze Quality Problems Analyze Non-Compliance Non-Conformance Categories Recording Evaluation Reporting and Requirements Corrective Action Post Activities As Build
Control Sheet Packing List
Specify
components; Performance
requirements {material, Dimensions,
attributes, etc}; Shelf life
{attributes} of stored drug; Repeatability
of advertised drug delivery; Performance
dynamics; Manufacturing
processes/methods; Drug
labeling system; and Part
numbering. Quality System
Certification Inquiry, Application, Assessment, Registration, Follow-up.
| home | back | inventions |
Compliance Consultants
1151 Hope Street
Stamford CT 06907 USA
voice 203 329 2700
fax 203 329 2345