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SERVICES

 

   

 

GOOD DOCUMENTATION PRACTICES (GDPs)

 

 

We can assist you to establish the needed Standard operating procedures and all other documents pertaining to Good Manufacturing Practices and Good Clinical Practices

 Our documents were written according to the FDA, Health Canada, ICH, and WHO Guidelines

 

 

 

 DEFINITION (WHAT IS A DOCUMENT?)

The document is information (meaningful data) and its supporting medium, which could be in paper form, CD, computer files, or microfilm.

When an organization develop (establish), and keep documents that describe (1) how the Quality Management System is applied to a specific product, (2) establish documents on product requirements (specifications), (3) establish documents to provide information about how the facility perform activities and processes (procedures), and (4) establish documents to provide objective evidence performed or results achieved (records), then the organization management can claim that they fulfill the Good Documentation Practices requirements.

Good Documentation Practices, in brief, enable communications of intent and consistency of actions (ISO-9000: 2000).

FUNDAMENTALS

 

DOCUMENTS PURPOSES 

The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are:

  1. To define the specifications and procedures for all materials and methods of manufacture and control

  2. To ensure that all personnel concerned with manufacturing know what to do and when to do it.

  3. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale.

  4. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation.

  5. And to ensure the availability of the data needed for validation, review, and statistical analysis.

DOCUMENTS TYPES (CATEGORIES)

The following are the types of documents, which organization should establish and keep:

  1. Guideline: To provide recommended practices and instructions.

  2. Policy: Is a document to establish the organization interpretation and attitude toward the regulatory body.

  3. Standard Operating Procedure (SOP): To provide detailed instructions on how to implement a process or perform a specific activity. 

  4. Record: Is a document, stating results achieved or providing evidence of activities performed.

  5. Forms and Templates: Are a pre-structured document with blank spaces designed for insertion of required information.

  6. Manual: To provide information on how a system or equipment operate.

DOCUMENTS FORMAT (AND MANAGEMENT)

  1. Documents should be designed, prepared, reviewed and distributed with care

  2. Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval.

  3. Documents should have unambiguous contents: the title, scope, and purpose should be clearly stated.

  4. Design and use of documents depend upon the corporate

  5. Documents should be regularly reviewed and kept up to date.

  6. Where documents require the entry of data, these entries should be clear, legible, and indelible.

  7. Any alteration made to a document should be signed and dated; the alteration should permit the reading of the original information. 

  8. Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable.

  9. Records should be retained for at least one year after the expiry date of the finished product.

  10. Data (and records for storage) may be recorded by electronic data-processing systems or by photographic or other reliable means.

  11. Master formula and detailed standard operating procedures relating to the system in use should be available and the accuracy of the records should be checked.

  12. If documentation is handled by electronic data-processing methods, only authorized persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions.

  13. Batch records stored electronically should be protected by back-up transfer on CD, microfilm, paper print-outs or other means. It is particularly important that, during the period of retention, the data are readily available.

REQUIRED DOCUMENTS

As indicated in WHO general principles of GMPs guideline for pharmaceutical products, the plant management should ensure that the following documents are prepared and available:  

  1. Specifications including tests on identity, content, purity and quality for starting and packaging materials and specifications for intermediate, finished, and bulk products.

  2. Specifications for water, solvents and reagents (e.g. acids and bases) used in production.

  3. Pharmacopoeias, reference standards, and other reference materials should be available in the quality control laboratory.

  4. A formally authorized master formula should exist for each product and batch size to be manufactured.

  5. Formally authorized packaging instructions should exist for each product, pack size and type.

  6. A batch processing record should be kept for each batch processed.

  7. Before any processing begins, a check should be made and recorded. (That the equipment is clean and work station are clear of previous products, documents, or materials not required for the planned process) 

  8. A batch packaging record should be kept for each batch or part batch processed. 

  9. Batch number allocation should be recorded, e.g. in a log­book. 

  10. Analysis records, the tests performed should be recorded

  11. Records should be maintained of the distribution of each batch of a product in order to facilitate the recall of the batch if necessary.

  12. Records should be kept for major and critical equipment of any:

  • Validations and Calibrations

  • Maintenance and repair operations and cleaning 

  1. The use of major and critical equipment and the areas where products have been processed should be recorded in chronological order.

  2. Standard operating procedures and associated records of actions taken should be available for:

  • Equipment assembly and validation

  • Analytical apparatus and calibration

  • Maintenance, cleaning, and sanitization

  • Personnel matters including qualification, training, and hygiene

  •  Environmental monitoring

  • Pest control and assigning responsibility for cleaning and sanitation

  • Written release and rejection procedures

  • Complaints, Recalls, Returns and Sampling

  • For testing materials and products at different stages of manufacture describing the methods and equipment to be used.

  • For describing the details of the batch (lot) numbering system

  • For the internal labelling, quarantine and storage of starting materials, packaging materials and other materials

  • For the receipt of each delivery of starting material and printed packaging material.

To apply the above fundamentals to actual regulations as described in the current GMPs guidelines, we present herein the documentation requirements as indicated in the FDA Dietary Supplement Rules,  compared with Health Canada; Natural Health Products GMPs documentation requirements.

 

FDA DIETARY SUPPLEMENT RULES

As a background information, on June 22, 2007, FDA announced a final rule establishing Good Manufacturing Practice requirements for dietary supplements. The final rule on GMPs is a critical component of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

This rule helps to ensure the quality of dietary supplements. According to the rule, the compliance date is 12 months after publication in the Federal Register, while businesses with fewer than 500 but more than 20 employees will have 24 months, and business of fewer than 20 employees will have 36 months.

 

FDA Vs HEALTH CANADA DOCUMENTATION REQUIREMENTS

The new FDA final rule on GMPs for dietary supplements, require the facility management to develop (make available) written procedures and records for almost every single activity in the facility.

Also, as per the natural health products GMPs guidance document, Health Canada (HC) requires manufacturers to retain in the premises 16 types of records. The absence of any of these records will be considered a deviation from the GMPs regulations, which may result in a non-compliant rating.  

 

Table (1) contains a list of documents that needed by US FDA and HC as guidance. The mark (√) in front of the document title means that the document is required.

 TABLE (1)

GMPs DOCUMENTS NEEDED BY USA FDA AND HEALTH CANADA

 

 

NO.

 

DOCUMENTS REQUIRED

 

HEALTH CANADA

 

US FDA

1

Master production document

2

Manufacturing order

3

Packaging order

4

Labeling order

5

Test results: raw material

6

Test results: packaging material

7

Test results: finished product

8

Specifications: raw material

9

Specifications: packaging material 

10

Specifications: finished product

11

Stability summary

 

12

Ingredients list

 

13

Products list

 

14

Distribution list

15

Complaints

16

Sanitation program

17

Approving/rejecting any reprocessing

 

18

Returned dietary supplements

 

19

lab operations

 

20

Receiving records 

 

21

Instruments calibration

 

22

In-process specifications

 

     

QMRS DOCUMENTATION SUPPORT

QMRS Documents Characteristics and Benefits

  1. These documents are in the Ready to Use form (MW). Thus, very little adjustments (changes) required to suit your organization

  2. QMRS can provide you with all the needed policies, guidelines, SOPs, forms, and audit check lists. This will assure consistency in style and format

  3. Since writing these documents requires a great deal of time, skills, and resources, certainly, you will save countless hours and days of your employee’s time for searching and writing.

  4. You will make advantages of our professionally researched and written documents.

  5. Enjoy free consultation by email. This will include free updating (if any) of any SOP within one year of purchasing the document (This service is upon your written request).

  6. Please click on the document title inside the tables or visit the ON-LINE PURCHASE page to learn more on how to obtain these documents.

  7. We offer an easy and secure credit card payment via, Pay Pal, by Cheque, or bank transfer in Canadian or US Dollar.

QMRS Standard Operating Procedures And Policies 

Table (2) contains a list of policies and procedures, which are available in our On-line store. These SOPs cover the most important aspects of health products GMPs. In table (3), you will find the available SOPs on almost all activities pertaining to clinical trials.

Please click on ON-LINE PURCHASE or on the document title inside the following tables to learn more on the purpose and price of the document. Also, if you have a question or could not find a specific document, please do not hesitate to contact us. Just send us your request to info@qmrs.com and promptly, we would be pleased to answer you.

To make you more confident about our products, please click SOP Sample to review a sample of our procedures.

 

Audit Checklists

Under Site License Section support (GMPs Audit), we discussed the three types of audit (First Party. Second Party and Third Party audit). As it was indicated, First Party audit is performed within the organization by its own employees. The objective is to assure development, maintenance, and improvement of the facility quality system in order to fulfill the applicable regulations. From the regulations requirements perspective, the audit checklist is a valid document to prove that the “internal audit program” is in place.

Therefore QMRS developed a number of auditing checklists, which are ready to purchase on-line.

Forms and Templates

As indicated above, FDA, WHO, and Health Canada require many types of records, which should be maintained in the manufacturers’ site.

QMRS designed/prepared a number of templates and forms to suit the industry need. If you need any assistance in this regard, please do not hesitate to call us on 613 526 0471, or write to info@qmrs.com to learn more about all other available documents.     

 

   TABLE (2):

AVAILABLE STANDARD OPERATING PROCEDURES AND POLICIES ON

Good Manufacturing Practices (GMPs)

 

SOPs AND POLICIES ON PERSONNEL

PER 002

PERSONNEL TRAINING

PER 004

QUALITY CONTROL/ASSURANCE PERSON RESPONSIBILITIES

PER 006

SANITATION: EMPLOYEES

PER 008

SANITATION: HAND WASHING

SOPs AND POLICIES ON PHYSICAL PLANT AND GROUNDS

PLC 001

HOUSEKEEPING

PLC 004

SANITATION: PEST CONTROL

PLC 006

SANITATION: APPROVAL OF DISINFECTANTS MATERIALS

PLC 008

MICROBIAL TESTING OF SURFACES

PLC 012

PLANT SEPARATION OF OPERATIONAL AREAS

PLC 014

STORAGE AND HANDLING OF RECEIVED MATERIALS

PLC 020

WATER SYSTEM AND QUALITY

SOPs AND POLICIES ON EQUIPMENTS

EQP 004

EQUIPMENT QUALIFICATION

EQP 006

EQUIPMENT VALIDATION

EQP 008

EQUIPMENT CLEANING VALIDATION POLICY

EQP 010

EQUIPMENT CLEANING: ACCEPTANCE CRITERIA CALCULATION

EQP 018

EQUIPMENTS CLEANING AND SANITIZING PROCEDURE

SOPs AND POLICIES ON PRODUCTION AND PROCESS CONTROL SYSTEM

OPR 030

INCOMING MATERIAL SPECIFICATION REQUIREMENTS

OPR 034

SAMPLING OF RECEIVED MATERIALS

OPR 038

CERTIFICATES OF ANALYSIS (COA)

OPR 042

FINISHED PRODUCTS SPECIFICATIONS (NHP: HC)

OPR 046

FINISHED PRODUCTS TRACKING NUMBER

OPR 050

MANUFACTURING PROCESSES: POWDER FORMULA

OPR 054

NON-CONFORMING FINISHED PRODUCT CONTROL

OPR 058

FINISHED PRODUCTS TESTING AND RELEASE

OPR 062

THIRD PARTY LABORATORY TESTING

OPR 066

STABILITY TESTING

OPR 072

SAMPLE RETENTION

SOPs AND POLICIES ON PRODUCT COMPLAINTS

OPR 080

PRODUCT COMPLAINT

OPR 084

PRODUCT RECALL

DOCUMENTS ON QUALITY ASSURANCE AND AUDIT CHECKLISTS

OPR 090

QUALITY ASSURANCE POLICY

OPR 092

GOOD DOCUMENTATION PRACTICES GUIDELINE

OPR 094

INTERNAL AUDIT CHECKLIST FOR DRUG-PRODUCING FACILITIES

OPR 096

INTERNAL AUDIT CHECKLIST FOR DIETARY SUPPLEMENTS-PRODUCING FACILITIES (US FDA parameters)

OPR 098

INTERNAL AUDIT CHECKLIST FOR NHP-PRODUCING FACILITIES (Health Canada parameters)

OPR 100

CORRECTIVE AND PREVENTIVE ACTION (CAPA) POLICY

SOPs AND POLICIES ON RECORDS AND RECORDKEEPING

OPR 110

DOCUMENTS CREATION (SOP ON SOPS)

OPR 112

DOCUMENTS (SOPS & POLICIES): DISTRIBUTION AND CONTROL

OPR 114

RECORDS RETENTION AND DATA STORAGE

OPR 116

PRODUCT MANUFACTURING: DOCUMENTATIONS REQUIREMENTS

OPR 118

COMMUNICATION WITH REGULATORY AUTHORITIES

OPR 120

MANAGING INFORMATION REQUEST AND DEFICIENCY NOTICE

SOPs AND POLICIES ON PACKAGING AND LABELLING OPERATIONS

OPR 130

PRINTED MATERIALS (LABEL): DEVELOPMENT

OPR 132

PRINTED MATERIALS: REVIEW AND APPROVAL

OPR 134

PRINTED MATERIALS: CONTROL

SOPs ON RETURNED HEALTH PRODUCTS

OPR 140

RETURN AND DESTRUCTION OF HEALTH PRODUCTS SUPPLIES

 

NOTE: PLEASE CLICK ON THE DOCUMENT TITLE FOR MORE INFORMATION


 

TABLE (3):

AVAILABLE STANDARD OPERATING PROCEDURES AND POLICIES ON

GOOD CLINICAL PRACTICES (GCPs)

 

CLN 001

CLINICAL TRIALS: PRINCIPLES

CLN 002

POST-MARKETING STUDIES

CLN 003

CONTRACT RESEARCH ORGANIZATION

CLN 004

PRE-TRIAL DOCUMENTATION

CLN 005

INVESTIGATOR SELECTION

CLN 006

CLINICAL TRIALS: SPONSOR RESPONSIBILITIES

CLN 007

CLINICAL TRIALS: INVESTIGATOR RESPONSIBILITIES

CLN 008

CLINICAL TRIALS: CONFIDENTIALITY AGREEMENT

CLN 009

RESEARCH ETHICS BOARD REVIEW/APPROVAL

CLN 010

INFORMED CONSENT FORM

CLN 011

CLINICAL CASE REPORT

CLN 012

SITE MASTER FILE

CLN 013

CLINICAL TRIAL MASTER FILE

CLN 014

CLINICAL SUPPLY ACCOUNTABILITY

CLN 015

INVESTIGATIONAL PRODUCT ADVERSE EVENT REPORTING

CLN 016

MANUFACTURING OF CLINICAL SUPPLY

CLN 017

PREPARATION OF CLINICAL TRIAL LABEL

CLN 018

SHIPMENT OF CLINICAL SUPPLY

CLN 019

INVESTIGATIONAL PRODUCT RECALL

CLN 020

RETURN AND DESTRUCTION OF CLINICAL SUPPLY

CLN 022

MANAGEMENT OF EXPIRED AND EXTENDED INVESTIGATIONAL SUPPLY

CLN 023

CLINICAL TRIAL TRAINING REQUIREMENTS

CLN 024

DECLARATION OF HELSINKI

CLN 025

CLINICAL TRIALS REGULATORY REQUIREMENTS

CLN 030

TRANSPORTATION OF BLOOD AND BLOOD COMPONENTS

CONTRACT RESEARCH ORGANIZATION (CRO)

CLN 040

CLINICAL TRIAL AUDIT

CLN 041

CLINICAL TRIALS: ESSENTIAL DOCUMENTS CHECKLIST (ICH PARAMETERS)

CLN 042

CONTRACT RESEARCH ORGANIZATION (CRO): ORGANIZATION CAPABILITIES (Section One)

CLN 043

CONTRACT RESEARCH ORGANIZATION (CRO): INVESTIGATIONAL SITE CAPABILITIES (Section Two)

CLN 044

CLINICAL LABORATORY EVALUATION CHECKLIST: (Section Three)

CLN 045

CONTRACT RESEARCH ORGANIZATION (CRO) EVALUATION CHECKLIST (The three sections CLN 042, CLN 043, AND CLN 044 combined).

 


 

NOTE: PLEASE CLICK ON THE DOCUMENT TITLE FOR MORE INFORMATION